Recall Z-0181-2026
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 FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
Codes / lots: FHCP08Y UDI-DI 191072232724 Lot 8216211 Bag serial number 68258296; HICS50I UDI-DI 191072212351 Lot 8161711 Bag serial number 68273637; HSCB90B UDI-DI 191072141606 Lot 8083511 Bag serial numbers 47506618 47508489 * If bag serial number is listed as "N/A", then whole lot is affected
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-0181-2026
- Initiated
- September 4, 2025
- Posted by FDA
- October 16, 2025
- Product code
- OHM – Cesarean Section 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-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-0184-2026 Class II | Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H…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 |