FDA Device recall Z-0184-2026
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRT…
- FDA Device
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRT… by American Contract Systems, citing 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 no….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0184-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-04 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | American Contract Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | AMEX26AA UDI-DI 191072207340 lot 7958811 bag serial number N/A; ANSH14AF UDI-DI 00191072214461 lot 8137411 bag serial…AMEX26AA UDI-DI 191072207340 lot 7958811 bag serial number N/A; ANSH14AF UDI-DI 00191072214461 lot 8137411 bag serial numbers 68274173 68274192; EVAH76H UDI-DI 191072221858 lot 8367611 bag serial number 68566760; FDSA15M UDI-DI 191072185396 lot 8076011 bag serial number 68117299; GRTS90G UDI-DI 191072208262 lot 8532411 bag serial number N/A; HGHI26G UDI-DI 191072212559 lot 8161611 bag serial number N/A; HJTO25C UDI-DI 191072105684 lot 8071011 bag serial numbers 17505916 17506159; HNEX60L 191072193643 lot 8487711 bag serial number 68641794; IAHD53C UDI-DI 191072232564 lot 8128911 bag serial number 47395092; IASH65A UDI-DI 191072224477 lot 8058211 bag serial number N/A; IHUE40AI UDI-DI 191072234100 lot 8181611 bag serial number N/A; ILTJ47AA UDI-DI 197012208279 lot 8518611 bag serial number 68865822; LMHP14Z UDI-DI 191072202932 lot 8136111 bag serial number N/A; LMSN44AE UDI-DI 191072236265 lot 8450311 bag serial number N/A; MHHP25H UDI-DI 191072214983 lot 7986811 bag seria |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0184-2026%22
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