Medical convenience kits Item Number/Description RCEN25B ENT SDSC… — Class II medical device recall Z-0178-2026
Ongoing recall by American Contract Systems Inc., reported 2025-10-22, distributed nationwide. Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the init
| Recall number | Z-0178-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Contract Systems Inc., Grimes, IA, United States |
| Recall initiated | 2025-09-04 |
| Classified | 2025-10-16 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 32,433 total |
| Reason classes | chemical contamination |
| UPC / GTIN / UDI-DI | 00191072225115, 00191072235923 |
| Lot numbers | 8138311, 8508211 |
| Serial numbers | 47847459, RCHN27D |
Product
Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0178-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.