Recall Z-0183-2026
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 HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL (PS 64405) UISH15AV SHUNT PACK (PS 039360)
Codes / lots: ANLM40AG UDI-DI 191072232076 Lot 8192111 Bag serial number 68195596; ANPP15AR UDI-DI 191072214423 Lot 8024911 Bag serial number 68055493; HSLM53AB UDI-DI 191072224095 Lot 8061111 Bag serial number 68138767; MILM82A UDI-DI 191072231512 Lot 8361111 Bag serial number 68576542; RCNA47B UDI-DI 191072228536 Lot 8441711 Bag serial number 68680026; SFLM54AB UDI-DI 191072217400 lot 8105511 Bag serial number N/A; UDLM94AA UDI-DI 191072214089 Lot 8382011 Bag serial number 17621919; UILM77AU UDI-DI 191072210333 Lot 8056311 Bag serial number N/A; UINR44P UDI-DI 191072210340 Lot 8067511 Bag serial numbers 68138618 68140374; UISH15AV UDI-DI 191072227843 Lot 8028211 Bag serial number 68154067 * 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-0183-2026
- Initiated
- September 4, 2025
- Posted by FDA
- October 16, 2025
- Product code
- OJG – Neurological 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-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 |