Medical convenience kits Item Number/Description ANSH14AF SHOULDER… — Class II medical device recall Z-0184-2026
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-0184-2026 |
|---|---|
| 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 | 00191072105684, 00191072185396, 00191072193643, 00191072202932, 00191072205407, 00191072207340, 00191072208262, 00191072208538, 00191072212559, 00191072214461, 00191072216120, 00191072216267, 00191072216298, 00191072221858, 00191072224477, 00191072225344, 00191072225740, 00191072226013, 00191072226266, 00191072228956, 00191072228970, 00191072229878, 00191072232564, 00191072234049, 00191072234100 and 2 more |
| Lot numbers | 7958811, 7974911, 7982511, 7986811, 7991811, 8025311, 8027311, 8040111, 8046511, 8047611, 8049011, 8058211, 8065011, 8071011, 8076011, 8128911, 8136111, 8137411, 8161611, 8172511, 8181611, 8192211, 8367611, 8411811, 8450311, 8487711, 8518611, 8532411 |
| Serial numbers | 17402072, 17505916, 17506159, 191072193643, 47394380, 47395092, 47498107, 68045970, 68117299, 68135550, 68137959, 68153822, 68153870, 68195746, 68274173, 68274192, 68566760, 68641794, 68666214, 68865822, ANSH14AF, EVAH76H, FDSA15M, GRTS90G, HGHI26G and 22 more |
Product
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C TOTAL HIP ACCESSORY PACK HNEX60L EXTREMITY PACK IAHD53C HAND PACK IASH65A SHOULDER PACK IHUE40AI UPPER EXTREMITY PK| STRL F G ILTJ47AA TOTAL JOINT PACK LMHP14Z ORIF HIP, ST LUKES METHODIS LMSN44AE SPINAL PACK MHHP25H HAND PACK - 206002 MHTH90AJ TOTAL HIP PACK - 206016 MWAH32P ANTERIOR HIP PACK MWTK13AH TOTAL KNEE PLOR89H ORTHO MINOR PACK RCUE81B UPPER EXTREMITY RCH 0247031 TSTH54D TOTAL HIP TRAY UDEX85Y DSC EXTREMITY - 206050 UDHD69U HAND PACK - 206055 UDKN68AH CUSTOM KNEE - 206061 UIHN18AW ACS HAND PACK (PS 020640) UIHN18AX ACS HAND PACK (PS 020640) UIKN28AR ASC KNEE PACK (PS 020641) UISO44I SFCH SMALL ORTHO PACK (PS 143213)
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-0184-2026. 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.