—#216298

Product

Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951

FDA product code: OGR — Ear, Nose, And Throat Surgical Tray
Device class: Class 1
Medical specialty: Ear, Nose, Throat
Affected lot / code info: RCEN25B UDI-DI 191072225115 lot 8138311 bag serial number N/A; RCHN27D UDI-DI 191072235923 lot 8508211 bag serial number 47847459 * If bag serial number is listed as "n/a", then entire lot is affected

Why it was recalled

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.

Recalling firm

Firm: American Contract Systems Inc.
Address: 1601 Se Gateway Dr, Ste 120, Grimes, Iowa 50111-5223

Distribution

Distribution pattern: US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Timeline

Recall initiated: 2025-09-04
Posted by FDA: 2025-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216298. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.