Recall Z-0184-2026 ยท OJH Orthopedic Tray
American Contract Systems Inc.
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 SPI
| Date | Oct 16, 2025 (initiated Sep 4, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 32,433 total |
| Distribution | US Nationwide distribution in the states of SD, IA, MN, WA, IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.