Recall Z-0180-2026

American Contract Systems Inc. · initiated September 4, 2025

Class II Open, Classified

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 HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224

Codes / lots: ANCA80AP UDI-DI 191072232168 Lot 8077111 Bag serial number 68119740; HSAN63N UDI-DI 191072232267 Lot 8097211 Bag serial number N/A; IHAN02W UDI-DI 191072201928 Lot 7961811 Bag serial number 68086881 Lot 8037411 Bag serial number N/A; MHCA98AK UDI-DI 191072216014 Lot 8006711 Bag serial number 47415134 Lot 8133011 Bag serial number N/A; RCAN45C UDI-DI 191072229632 Lot 8537111 Bag serial number 68872542; UDCO10F UDI-DI 191072216236 Lot 7987811 Bag serial number N/A * 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-0180-2026
Initiated
September 4, 2025
Posted by FDA
October 16, 2025
Product code
OEQ – Angiography/Angioplasty Kit
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

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0170-2026 Class IIBasic 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 IIBasic 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 IIMedical 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 IIMedical 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 IIMedical 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 IIMedical 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 IIMedical 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 IIMedical 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 IIMedical 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 IIMedical 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-0181-2026 Class IIMedical 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 IIMedical 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 IIMedical 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 IIMedical 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 IIMedical 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 IIMedical 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 IIMedical 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