FDA warning letters about medical device marketing claims
This page lists FDA warning letters, dated from January 2024, that cite a company's own website, brochure, labeling, video, talk or store listing as showing a use, a claim or an FDA status the product did not have. Each row gives the product, where the claim appeared, what FDA objected to and a one-line summary of the letter, with a link to FDA's copy. The list is checked against FDA's warning letter database every month.
55 letters. Last updated .
Each summary is in Buzzbox Media's words and the linked letter is the source. A warning letter states FDA's position when it was sent, not a final ruling. This page is not legal or regulatory advice.
Monthly notes
October 2026: 2 letters added, posted by FDA between October 20, 2026 and October 27, 2026.
- Use outside the clearance or approval: 1 letter. What to check: Compare every condition, patient group and setting named in your marketing with your indications for use.
- Use outside a 510(k) exemption: 1 letter. What to check: Compare every use named in your marketing with the device type your listing relies on and its limits.
Checked November 9, 2026 against FDA's warning letter database.
September 2026: 2 letters added, posted by FDA on September 22, 2026.
- Use outside the clearance or approval: 1 letter. What to check: Compare every condition, patient group and setting named in your marketing with your indications for use.
- Use outside a 510(k) exemption: 1 letter. What to check: Compare every use named in your marketing with the device type your listing relies on and its limits.
Checked November 9, 2026 against FDA's warning letter database.
August 2026: No letters matching this list were posted by FDA between August 1, 2026 and August 31, 2026.
Checked November 9, 2026 against FDA's warning letter database.
The letters
Download the list as a CSV file
-
Letter date
Posted by FDA
Tides Medical LLC
Product APLICOR 3D
Summary The website described a 3D bioprinting system that turns a patient's fat tissue into wound grafts; FDA says this is a use outside the liquid medication dispenser device type the firm said the product fits.
- What FDA objected to
- Use outside a 510(k) exemption
- Where the claim appeared
- website
- Issuing office
- Center for Biologics Evaluation and Research
- Sections cited
- 501(f)(1)(B); 502(o)
-
Letter date
Posted by FDA
Chirp Innovations, LLC
Product Chirp Halo wireless muscle stimulator
Summary Webpages and a product bundle promoted a TENS unit cleared for muscle and exercise pain as relief for period cramps; FDA says this is outside the clearance.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
Advance-Esthetic LLC
Product Zemits CrystalFrax Pro, Abigon Pro and Bionexis Lite Pro
Summary The website and a linked video promoted radiofrequency and light devices, listed as therapeutic massagers, to "reduce cellulite appearance" and as stimulating collagen; FDA says the devices' technology and these uses are outside the massager device type, so the devices are not exempt from 510(k).
- What FDA objected to
- Use outside a 510(k) exemption
- Where the claim appeared
- website; video
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(o)
-
Letter date
Posted by FDA
Specialty Health Products CO, LLC
Product Hydro-San Plus colon irrigation system
Summary The website, catalog and user's guide promoted the device for professional colon hydrotherapy, and the product webpage listed benefits including relief of constipation, lower risk of cancer and better retention of vitamins and nutrients; FDA says these uses are outside the clearance.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- website; brochure, catalog or other marketing material; labeling or manual
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
Happiest Baby, Inc.
Product SNOO Smart Sleeper, X-Small sleep sack and SNOO Hospital Bundle
Summary The website sold a sleep sack for infants from 4 lbs and marketed the home bassinet to hospitals; FDA says both are outside the De Novo authorization.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- website; brochure, catalog or other marketing material
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
Nihon Kohden Digital Health Solutions, LLC
Product Next Generation NetKonnect alarm software
Summary Labeling described "device-agnostic compatibility"; FDA says this is beyond the scope of the cleared intended use, and that an alarm silencing feature the firm added needed a new 510(k).
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- labeling or manual
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(o)
FDA letter: Nihon Kohden Digital Health Solutions, LLC, Jun 12, 2026
-
Letter date
Posted by FDA
AseptiKits, LLC
Product PALA YourTears, ALAdrop, SyrilKit and VitrALA kits
Summary The website said the kits' devices are "510(k) approved" and that the kits "Meets or exceeds FDA regulations"; FDA says the products have no clearance or approval and these statements are false and misleading.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- website
- FDA status wording
- Yes
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(a); 502(o)
-
Letter date
Posted by FDA
BlephEx, LLC
Product BlephEx powered eyelid cleaning sponge
Summary Videos on the website, including a news story, promoted the BlephEx sponge for blepharitis, dry eye and use before cataract or LASIK surgery; FDA says these are uses outside the exempt device type.
- What FDA objected to
- Use outside a 510(k) exemption
- Where the claim appeared
- website; video
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
ZIIP, Inc.
Product ZIIP Halo 2.0, ZIIP DOT and ZIIP gels
Summary Promotion claimed the ZIIP Halo 2.0 boosts collagen, fades pigmentation and plumps lips and the ZIIP DOT reduces spots and cuts redness by 87%; FDA says neither device has clearance, and the cleared ZIIP models are for facial and neck stimulation.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- website; labeling or manual
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o)
-
Letter date
Posted by FDA
3B Medical, Inc. dba Reach Health, Inc.
Product Luna CPAP and Auto CPAP (APAP) devices
Summary User manuals posted on the website said the single-patient devices can be reused across patients in hospitals; FDA says this is outside the clearance.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- labeling or manual; website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o); 502(t)(2)
FDA letter: 3B Medical, Inc. dba Reach Health, Inc., May 20, 2026
-
Letter date
Posted by FDA
Skytron, LLC
Product UV-C disinfection systems (1140 Sentry, 2280 Syndicate, 3200 Max, UV Smart D25)
Summary Webpages and brochures promoted UV devices for hospital and medical equipment disinfection and called one "the first FDA registered" device, after the firm said in 2024 it had removed such claims.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- website; brochure, catalog or other marketing material; video
- FDA status wording
- Yes
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(a); 502(o)
-
Letter date
Posted by FDA
Estar Technologies Ltd
Product Tropocells PRP, PRF and related blood kits
Summary Websites promoted a PRP kit cleared for mixing with bone graft for joint, sports injury, wound, eye and dental healing, and offered related kits FDA found not cleared as marketed.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- website
- Issuing office
- Center for Biologics Evaluation and Research
- Sections cited
- 501(f)(1)(B); 502(o)
-
Letter date
Posted by FDA
Longhorn Vaccines and Diagnostics LLC
Product PrimeStore MTM sample transport medium
Summary The website and brochure claimed more organisms, sample types, better sensitivity and antibiotic resistance gene detection; FDA says the authorization covers influenza only.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- website; brochure, catalog or other marketing material
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o); 502(t)(2)
FDA letter: Longhorn Vaccines and Diagnostics LLC, Feb 26, 2026
-
Letter date
Posted by FDA
ExThera Medical Corporation
Product Seraph 100 blood filter
Summary ExThera's chief medical officer said in a podcast, a conference talk and a promotional video that the filter is "approved in the US for COVID-19" and spoke of using it for outpatients with cancer, long COVID, chronic viremia and chronic Lyme and to "treat the disease of aging"; FDA says the device has no approval for any use.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- website; video; talk or interview
- FDA status wording
- Yes
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(i); 502(a); 502(o)
-
Letter date
Posted by FDA
Early to Bed, Inc.
Product Breast binders (resold)
Summary A retailer's website sold binders whose maker says they reduce swelling after top surgery and cause "gender euphoria"; FDA says those claims make the binders medical devices, and that they came from an establishment not registered with FDA.
- What FDA objected to
- Claims made a general product a device
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 502(o); 510 (registration)
- Close‑out
- Close-out letter posted Mar 31, 2026
-
Letter date
Posted by FDA
FLAVNT Streetwear, LLC
Product Breast binders
Summary The website described binders in terms of dysphoria relief and safety; FDA says these claims make the binders medical devices, and that the firm had not registered with FDA or listed the binders for fiscal year 2026.
- What FDA objected to
- Claims made a general product a device
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 502(o); 510 (registration)
- Close‑out
- Close-out letter posted Mar 31, 2026
-
Letter date
Posted by FDA
Flux Lab Pte. Ltd. d/b/a The Fluxion
Product Breast binders
Summary The website presented binders as a product for people with gender dysphoria; FDA says these claims make the binders medical devices, and that the firm had not registered with FDA or listed the binders for fiscal year 2026.
- What FDA objected to
- Claims made a general product a device
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 502(o); 510 (registration)
- Close‑out
- Close-out letter posted Apr 7, 2026
FDA letter: Flux Lab Pte. Ltd. d/b/a The Fluxion, Dec 16, 2025
-
Letter date
Posted by FDA
For Them, Inc.
Product Breast binders
Summary Website content discussed managing chest dysphoria with binders; FDA says these claims make the binders medical devices, and that the firm had not registered with FDA or listed the binders for fiscal year 2026.
- What FDA objected to
- Claims made a general product a device
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 502(o); 510 (registration)
- Close‑out
- Close-out letter posted Mar 31, 2026
-
Letter date
Posted by FDA
GenderBender LLC
Product Breast binders
Summary The website linked binding to gender euphoria and said its compression wraps are for "wearing after top surgery to keep swelling down"; FDA says these claims make the binders medical devices, and that the firm had not registered with FDA or listed the binders for fiscal year 2026.
- What FDA objected to
- Claims made a general product a device
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 502(o); 510 (registration)
- Close‑out
- Close-out letter posted Apr 2, 2026
-
Letter date
Posted by FDA
Marli Washington Design, LLC
Product gc2b breast binders
Summary The website said the binders help relieve dysphoria; FDA says these claims make the binders medical devices, and that the firm had not registered with FDA or listed the binders for fiscal year 2026.
- What FDA objected to
- Claims made a general product a device
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 502(o); 510 (registration)
- Close‑out
- Close-out letter posted Apr 2, 2026
-
Letter date
Posted by FDA
Philadelphia 7, Inc d/b/a Passional Boutique
Product Breast binders (resold)
Summary A retailer's website sold binders whose maker says they help reduce gender dysphoria; FDA says that claim makes the binders medical devices, and that they came from an establishment not registered with FDA.
- What FDA objected to
- Claims made a general product a device
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 502(o); 510 (registration)
- Close‑out
- Close-out letter posted Apr 6, 2026
FDA letter: Philadelphia 7, Inc d/b/a Passional Boutique, Dec 16, 2025
-
Letter date
Posted by FDA
ShapeShifter Apparel, LLC
Product Breast binders
Summary The website listed gender dysphoria as a reason to bind; FDA says these claims make the binders medical devices, and that the firm had not registered with FDA or listed the binders for fiscal year 2026.
- What FDA objected to
- Claims made a general product a device
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 502(o); 510 (registration)
-
Letter date
Posted by FDA
TG Supply LLC d/b/a TransGuy Supply
Product Breast binders
Summary The website said its binders are vetted for dysphoria relief and chest safety; FDA says these claims make the binders medical devices, and that the firm had not registered with FDA or listed the binders for fiscal year 2026.
- What FDA objected to
- Claims made a general product a device
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 502(o); 510 (registration)
- Close‑out
- Close-out letter posted Apr 6, 2026
FDA letter: TG Supply LLC d/b/a TransGuy Supply, Dec 16, 2025
-
Letter date
Posted by FDA
TOMSCOUT
Product Breast binders
Summary The website said binders help reduce gender dysphoria; FDA says these claims make the binders medical devices, and that the firm had not registered with FDA or listed the binders for fiscal year 2026.
- What FDA objected to
- Claims made a general product a device
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 502(o); 510 (registration)
- Close‑out
- Close-out letter posted Apr 7, 2026
-
Letter date
Posted by FDA
TomboyX, PBC
Product Compression tops (breast binders)
Summary The website tied its compression tops to managing dysphoria; FDA says these claims make the binders medical devices, and that the firm had not registered with FDA or listed the binders for fiscal year 2026.
- What FDA objected to
- Claims made a general product a device
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 502(o); 510 (registration)
- Close‑out
- Close-out letter posted Apr 7, 2026
-
Letter date
Posted by FDA
Trans-Missie B.V.
Product UNTAG breast binders
Summary The website said binders reduce dysphoria and improve mental health; FDA says these claims make the binders medical devices, and that the firm had not registered with FDA or listed the binders for fiscal year 2026.
- What FDA objected to
- Claims made a general product a device
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 502(o); 510 (registration)
-
Letter date
Posted by FDA
Physitemp Instruments, LLC
Product Clinical electronic thermometers and temperature probes
Summary The brochure and website described continuous hospital temperature monitoring, including during cancer hyperthermia and bypass surgery; FDA says thermometers with continuous measurement are not exempt and need clearance.
- What FDA objected to
- Use outside a 510(k) exemption
- Where the claim appeared
- website; brochure, catalog or other marketing material
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(c); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
Technological Medical Advancements LLC
Product Diowave 100 WLS and 250 WLS laser systems
Summary Brochures and the website promoted a micro-pulse laser for pain treatment under the infrared heat lamp device type; FDA notes the firm's brochure says there is "no heat during treatment," while that device type provides topical heating.
- What FDA objected to
- Use outside a 510(k) exemption
- Where the claim appeared
- website; brochure, catalog or other marketing material; labeling or manual
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(c); 502(o)
FDA letter: Technological Medical Advancements LLC, Sep 26, 2025
-
Letter date
Posted by FDA
LifeVac, LLC
Product LifeVac Rescue Suction Device
Summary The website and marketing materials sold an anti-choking suction device that FDA says has no marketing authorization, after FDA told the firm in June 2025 to stop marketing it until authorized.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- website; brochure, catalog or other marketing material
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B)
- Close‑out
- Close-out letter posted Mar 4, 2026
-
Letter date
Posted by FDA
The Richline Group, Inc.
Product Inverness Ear Care Antiseptic and Ear Care Solution
Summary The Ear Care Antiseptic label named benzalkonium chloride as the active ingredient for use as an ear care antiseptic; FDA says this goes beyond claims appropriate for a wound wash, and that the ear care products had no authorization.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- labeling or manual
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(c); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
SeniorLife Technologies, Inc.
Product SeniorLife.AI mobile app
Summary The website said AI agents for mobility and cognitive health give caregivers "a quick pre-diagnosis" and called the device "FDA Certified", and the app store pages it linked to showed the FDA logo and "FDA Approved".
- What FDA objected to
- Use outside a 510(k) exemption
- Where the claim appeared
- website; online store listing
- FDA status wording
- Yes
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(a); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
Les Encres LLC
Product Les Encres PDO barbed threads
Summary A website FAQ and a product listing promoted the sutures for face, jaw and neck lifts and adding volume; FDA says the clearance covers closing soft tissue only.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- website; brochure, catalog or other marketing material
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o)
-
Letter date
Posted by FDA
Spectra Therapy, LLC
Product LASERwrap infrared lamp system
Summary The website and manual listed treatment of IBS, wounds, urinary tract infections and tendonitis; FDA says these are uses outside the exempt infrared lamp device type.
- What FDA objected to
- Use outside a 510(k) exemption
- Where the claim appeared
- website; labeling or manual
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
WHOOP, Inc.
Product WHOOP Blood Pressure Insights feature
Summary The website offered daily blood pressure estimates and listed the feature as an example of "medical-grade health & performance insights"; FDA says the feature has no authorization for any use.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- website; article
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(o)
- Close‑out
- Close-out letter posted Jun 23, 2026
-
Letter date
Posted by FDA
Mectronic Medicale S.R.L.
Product Doctor Tecar therapy devices
Summary Marketing materials promoted the Doctor Tecar devices for carpal tunnel syndrome and faster healing; FDA says these claims are outside the scope of the devices' clearances.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- brochure, catalog or other marketing material
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
Insightra Medical Inc.
Product Ultra 7FR intra-aortic balloon pump catheter
Summary The website and a certificate of compatibility posted on it listed the Cardiosave IABP Hybrid and AutoCat 3 pump consoles as compatible, in addition to the consoles named in the firm's 510(k), and a slide deck on the website said "Compatible with all common Datascope and Arrow consoles"; FDA says listing the two added consoles is a significant change to the device's intended use that requires a new 510(k).
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- website; brochure, catalog or other marketing material; slide deck
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(A); 501(h); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
DRG Instruments GmbH
Product Salivary Cortisol ELISA (research use only version)
Summary The firm's website described a cortisol test labeled for research use only as for "quantitative in vitro diagnostic measurement" and listed clinical applications such as "Diagnosis of systemic/local conditions"; FDA says this shows an intended clinical use the test is not cleared for.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
Rex Implants Inc.
Product PiezoImplant REX BL 2.9 dental implant system
Summary The website and instructions described a surgical technique and uses that, FDA says, differ from the cleared implant system.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- website; labeling or manual
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(o)
-
Letter date
Posted by FDA
Next Science LLC
Product XPERIENCE, BLASTX and SURGX wound products
Summary The website and marketing materials promoted XPERIENCE for surgical wound sites, implants and orthopedic surgery, saying results were "more favorable compared to 10% Betadine", BLASTX for lowering inflammation and "Fewer Amputations", and SURGX for reducing surgical site infections; FDA says these uses go beyond the products' clearances.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- website; brochure, catalog or other marketing material
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
Red Oak Instruments, LLC
Product RU-FIT grip and reaction test (Model SR-3053)
Summary Website and training slides presented a grip strength device as a concussion (mild brain injury) screen.
- What FDA objected to
- Use outside a 510(k) exemption
- Where the claim appeared
- website; slide deck
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
Exer Labs, Inc.
Product Exer Scan AI motion analysis software
Summary The website said "Use Clinical AI to Diagnose and Treat MSK Disorders" and "AI-Based Screening for MSK Disorders in Neurology"; FDA says this is a use different from the exempt exercise measurement device type the firm relied on.
- What FDA objected to
- Use outside a 510(k) exemption
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o)
-
Letter date
Posted by FDA
Robbins Instruments, LLC
Product Dermo-Jet needleless injector
Summary The instructions for use and a brochure listed uses from vaccinations and local anesthesia to injections for skin conditions such as psoriasis and acne; FDA says the injector has no clearance or approval.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- brochure, catalog or other marketing material; labeling or manual
- Issuing office
- ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality
- Sections cited
- 501(f)(1)(B); 501(h); 502(o); 502(t)(2); 510 (registration)
-
Letter date
Posted by FDA
Anne’s Daye Ltd dba Tampon Innovations
Product CBD Daye tampons and Vaginal Microbiome Screening Kit
Summary The firm's website, a Walmart listing and a CEO interview promoted the CBD tampon for period pain, and the website and the firm's Amazon store promoted the at-home tampon screening kit, for example "Understand your risk of vaginal infections like yeast infection or BV, STIs, fertility implications, and other gynecological health complications"; FDA says the tampon's clearance covers absorbing menstrual discharge and not a CBD coated tampon, and that the screening kit has no clearance or approval.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- website; online store listing; talk or interview
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(o)
FDA letter: Anne’s Daye Ltd dba Tampon Innovations, Dec 17, 2024
-
Letter date
Posted by FDA
Shenzhen Moyeah Intelligent Life Technology Co.
Product Moyeah ozone CPAP cleaners
Summary Two websites described the ozone and UV cleaners as disinfecting and sterilizing CPAP devices and accessories, including a "Sterilization rate of 99.99%"; FDA says the devices have no clearance or approval.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(o)
FDA letter: Shenzhen Moyeah Intelligent Life Technology Co., Aug 8, 2024
-
Letter date
Posted by FDA
Adventure Innovations LLC
Product Sani Bot D3 CPAP cleaner
Summary An Amazon store listing said the ultrasonic CPAP equipment cleaner helps "Prevent congestion, and sickness" and "Improves Sleep, Removes Congestion, Reduces Headaches"; FDA says the device has no clearance or approval.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- online store listing
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(o)
-
Letter date
Posted by FDA
LEEL Tech
Product CLYN CPAP cleaners
Summary The website described the ozone cleaners as disinfecting or sanitizing CPAP machines and accessories, for example "to sanitize and disinfect your CPAP machine, mask and tubing thoroughly"; FDA says the devices have no clearance or approval.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(o)
-
Letter date
Posted by FDA
Natures Pillows, Inc. and Top Dog Direct, LLC
Product Clean Zone CPAP Sanitizer
Summary The website said the Clean Zone sanitizer reaches "every corner of your CPAP machine, tube and mask, killing 99% of germs and bacteria"; FDA says the device has no clearance or approval.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(o)
FDA letter: Natures Pillows, Inc. and Top Dog Direct, LLC, Aug 7, 2024
-
Letter date
Posted by FDA
Baylab USA, LLC
Product ASTM Level 3 surgical masks, Level 1 mask and KN95 respirator
Summary The website sold Level 3 mask versions (children's, anti-fog, new colors and materials) that FDA says are outside the clearance, and the labeling and website for a Level 1 mask and a KN95 respirator claimed filtration efficiency and fluid resistance; FDA says neither has clearance.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- website; labeling or manual
- Issuing office
- OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality
- Sections cited
- 501(f)(1)(B); 501(h); 502(c); 502(o); 502(t)(2)
- Close‑out
- Close-out letter posted Sep 14, 2026
-
Letter date
Posted by FDA
AG Essence, Inc.
Product Banda-SiL silver wound dressings
Summary The website said the silver dressings prevent infection and stimulate wound healing; FDA says these claims go beyond those appropriate for that type of wound dressing, and the dressings had no clearance.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(c); 502(o); 502(t)(2); 510 (registration)
-
Letter date
Posted by FDA
Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs
Product Second Generation FIT fecal immunochemical test
Summary The insert, brochure and website promoted the stool test for colon cancer screening; FDA says this is a significant change to the cleared device's intended use, and that the website still carried the claims on the date of the letter after the firm said during the inspection they would be removed.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- website; brochure, catalog or other marketing material; labeling or manual
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o); 502(t)(2)
FDA letter: Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs, Apr 17, 2024
-
Letter date
Posted by FDA
Agena Bioscience, Inc.
Product iPLEX HS Colon Panel on the MassARRAY 4 system
Summary The website said the colon panel can "Detect more than 80 clinically relevant variants across BRAF, EGFR, KRAS, NRAS, and PIK3CA" and carried customer stories about the firm's system from a hospital system and a state newborn screening program, alongside a research use only label; FDA says the panel is intended for clinical diagnostic use and has no clearance or approval.
- What FDA objected to
- Medical claims with no clearance or approval
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(o); 502(t)(2)
-
Letter date
Posted by FDA
Sol-Millennium Medical, Inc.
Product InviroStripe luer lock syringes
Summary Promotion showed syringe versions and a low dead space claim that, FDA says, the cleared syringe does not cover.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- brochure, catalog or other marketing material
- Issuing office
- Division of Medical Device and Radiological Health Operations Central
- Sections cited
- 501(f)(1)(B); 501(h); 502(b); 502(o); 502(t)(2)
- Close‑out
- Close-out letter posted Jan 5, 2026
-
Letter date
Posted by FDA
Trexo Robotics Holdings Inc.
Product Trexo robotic gait trainer for children
Summary The website and labeling described the device as "robotic legs to help children with mobility challenges get upright and walk independently"; FDA says this is a use outside the exempt isokinetic testing device type the firm listed it under.
- What FDA objected to
- Use outside a 510(k) exemption
- Where the claim appeared
- website; labeling or manual
- Issuing office
- OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality
- Sections cited
- 501(f)(1)(B); 501(h); 502(o)
-
Letter date
Posted by FDA
Soulaire Corporation
Product Soulaire external counterpulsation (ECP) system
Summary The website promoted the cleared ECP system for growing new arteries, cutting blood pressure medicine, COVID-19 symptoms, organ repair and hair growth.
- What FDA objected to
- Use outside the clearance or approval
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 502(o)
- Close‑out
- Close-out letter posted Aug 31, 2026
-
Letter date
Posted by FDA
Dr. Joel Kaplan Inc.
Product Penis pump systems (powered and manual)
Summary The website said the pumps increase length and thickness and correct mild curvature; FDA says these are uses outside the external penile rigidity device type the firm listed the product under.
- What FDA objected to
- Use outside a 510(k) exemption
- Where the claim appeared
- website
- Issuing office
- Center for Devices and Radiological Health
- Sections cited
- 501(f)(1)(B); 501(h); 502(o)
- Close‑out
- Close-out letter posted Mar 3, 2026
What each field means
- Letter date
- The date printed on the letter. Counts and the year filter use this date.
- Posted by FDA
- The date FDA added the letter to its public database. In this list it ranges from the same day to 139 days later (median 21).
- Company
- As named in the letter.
- Product
- The product named in the letter.
- Issuing office
- The FDA office that signed the letter: CDRH or one of its offices, CBER for the devices it regulates, or an FDA field division.
- Where the claim appeared
- The places the letter cites as evidence: website; brochure, catalog or other marketing material; labeling or manual; video; online store listing; talk or interview; slide deck; article. It is not a list of everywhere the claim appeared.
- What FDA objected to
- One of four, assigned by Buzzbox Media from the letter text. What to check on your own materials for each:
- Use outside the clearance or approval: Compare every condition, patient group and setting named in your marketing with your indications for use.
- Use outside a 510(k) exemption: Compare every use named in your marketing with the device type your listing relies on and its limits.
- Medical claims with no clearance or approval: List every health claim your marketing makes and check whether your product has the clearance or approval it would need.
- Claims made a general product a device: Check whether any health claim on a general product describes treating, preventing or affecting a medical condition.
- FDA status wording
- "Yes" when the letter says the marketing used FDA status wording that was false or misleading (for example "FDA Approved," "510(k) approved," "FDA registered" in a way that implied approval).
- Sections cited
- Every section of the FD&C Act the letter cites. Some concern problems other than marketing. Key: 501(f)(1)(A) and (B), the product lacks a required premarket approval; 501(h), quality system; 501(i), investigational device rules; 502(a), false or misleading labeling; 502(c), required information not prominent; 502(o), a required 510(k), registration or listing was not provided; 502(t)(2), adverse event reporting; 510, registration and listing.
- Summary
- A one-line summary of what FDA's letter says, in Buzzbox Media's words. The letter is the source.
- FDA letter
- Link to fda.gov.
- Close‑out
- Shows "Close-out letter posted" and the date when FDA has posted one; otherwise blank.
How this list is built
This list covers FDA warning letters dated January 1, 2024 or later in which FDA cites a company's own website, brochure, labeling, video, talk or store listing as showing a use, a claim or an FDA status the product did not have; dates and counts use the date on the letter, not the date FDA posted it.
The source is FDA's warning letter database. Includes letters from FDA's device center (CDRH) and its offices, from its biologics center (CBER) for the devices it regulates, and from an FDA field division. Letters about only manufacturing, quality or reporting problems are left out, and so are letters where marketing is mentioned only in passing. This is Buzzbox Media's definition, not FDA's; FDA does not label letters as being about promotion. Reviews that use other definitions report different totals. Each row is a one-line summary in Buzzbox Media's words; the letter is the source.
Caveats
- FDA posts letters late. In this list FDA posted letters from the same day to 139 days after the date on the letter. The most recent months will grow.
- Warning letters only. FDA also raises marketing problems through untitled letters, "It has come to our attention" letters, emails and calls, which are not in its public database and are not here.
- Redactions and removals. FDA redacts some text and removes some letters from its site. Each row was checked against the letter as posted on the date shown.
- A warning letter is FDA's position, not a final ruling. FDA describes warning letters as informal and advisory. The company may have responded, disagreed or corrected the problem. Read the full letter, and any close-out letter, before drawing conclusions about a company.
This page summarizes public FDA letters. It is not legal or regulatory advice. A warning letter states FDA's position when it was sent; read the full letter, and any close-out letter, before drawing conclusions about a company. Inclusion here is not a statement by Buzzbox Media about any company's products.
Check your own claims against your clearance
Book a free 30‑minute call and bring your website. Baron Miller will look at a few of its claims against your clearance with you. It is a marketing conversation, not a regulatory opinion.
How Buzzbox Media checks claims
Last updated
