Recall Z-0184-2026
American Contract Systems Inc. · initiated September 4, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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)
Codes / lots: 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 serial number N/A; MHTH90AJ UDI-DI 191072216120 lot 7982511 bag serial number N/A; MWAH32P UDI-DI 191072208538 lot 7974911 bag serial number N/A; MWTK13AH UDI-DI 191072225344 lot 8040111 bag serial number N/A; PLOR89H…
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0184-2026
- Initiated
- September 4, 2025
- Posted by FDA
- October 16, 2025
- Product code
- OJH – Orthopedic Tray
- Quantity
- 32,433 total
- Distribution
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- Recalling firm
- American Contract Systems Inc., Grimes, IA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0170-2026 Class II | Basic Biopsy Tray, Item Number NMBP44LIdentified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0171-2026 Class II | Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0172-2026 Class II | Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0173-2026 Class II | Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK -…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0174-2026 Class II | Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK -…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0175-2026 Class II | Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0176-2026 Class II | Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0177-2026 Class II | Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0178-2026 Class II | Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0179-2026 Class II | Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0180-2026 Class II | Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0181-2026 Class II | Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0182-2026 Class II | Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACKIdentified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0183-2026 Class II | Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0185-2026 Class II | Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0186-2026 Class II | Medical convenience kits UDPG88W PICC G-TUBE PACK-230209Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0187-2026 Class II | Medical convenience kits IHDC30R D AND C PACKIdentified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |