The U.S. Food and Drug Administration Center for Devices and Radiological Health published on November 3, 2026 a warning letter dated August 19, 2026 (CMS 727918) to Next Medical Products Company, LLC. It finds non-sterile Clear Image and MediChoice ultrasound gels adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.
US manufacturers of non-sterile ultrasound coupling gel, private-label and OEM brands of ultrasound gel sold into US hospitals, US importers and distributors of ultrasound gel, and US device makers that changed a cleared ultrasound-gel formulation without a new 510(k) must immediately review environmental monitoring, CAPA inputs and design-change control, file a new 510(k) when a preservative or formulation change can affect safety or effectiveness, and submit a 21 CFR 806 report of correction or removal within 10 working days when contamination presents a risk to health, or FDA may seize product, seek an injunction and civil money penalties, and refuse Certificates to Foreign Governments. A 510(k) is the notification a firm must give FDA under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 USC 360(k)), of its intent to introduce a device into commercial distribution, including after a formulation change that could significantly affect safety or effectiveness under 21 CFR 807.81(a)(3)(i).
- Authority : FDA Center for Devices and Radiological Health
- Entity : Next Medical Products Company, LLC
- Measure and amount : warning letter, no fine at this stage
- Legal basis : 21 CFR 820.70(c), 820.100(a), 820.30(i), 806.10 and 807.81(a)(3)(i)
- Decision date : August 19, 2026 (posted November 3, 2026)
- Appeal or compliance window : fifteen business days from receipt, for this firm only
- Official source : FDA warning letter CMS 727918
What happened
The December 10, 2025 FDA 483 stayed open after the January 2 and March 19, 2026 replies. Counts of 4,100 CFU, 4,000 CFU and at least 25,000 CFU on September 29, 2025 drew no CAPA. On July 23, 2025 the firm offered replacement or disposal for Paraburkholderia lots, with no 21 CFR 806 report on file as of August 13, 2026.
The breach
Procedure 907-030 neither investigates a failed environmental count nor defines a "significant finding," and procedure 908-019 omits CAPA inputs. A contraindication label and a 2024 Paraburkholderia-aimed preservative change skipped design verification. The letter states: "Failure to submit a Report required by 21 CFR 806.10 to FDA, within 10 working days of initiating the correction or removal." Clear Image (K883917) needs a new 510(k) under 21 CFR 807.81(a)(3)(i). Corrections follow the QMSR effective February 2, 2026 (QMSR questions).
Who else is in the same regime
The same duties bind other US makers, private-label brands, importers and distributors of non-sterile ultrasound gel, and firms that changed a cleared formula without a new 510(k). Obsidian tracks 14 regulatory texts under FDA 21 CFR in the United States as of November 2026.
What to check now
- Investigate each failed environmental count and record why a first result is discarded (21 CFR 820.70(c)).
- Route environmental failures, late lab shipments and odor or cloudiness complaints into CAPA (21 CFR 820.100(a)).
- Put a preservative change through design verification and a new 510(k) when it can affect safety (21 CFR 820.30(i) and 807.81(a)(3)(i)).
- File a correction or removal report within 10 working days of a replacement or disposal notice (21 CFR 806.10).
