FDA Device recall Z-0175-2026

Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CAR…

FDA Device
Class II
ongoing
Published 2025-10-22

On 2025-10-22 the FDA classified a Class II recall of Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CAR… by American Contract Systems, citing 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 no….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0175-2026
Classification	Class II
Status	ongoing
Initiated	2025-09-04
Published	2025-10-22
Last updated	2026-09-13 11:57 UTC
Company	American Contract Systems
Distribution	US

Product

Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)

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.

Identifiers

code_info	AMCL05P UDI-DI 191072207296 Lot 7990011 Bag serial no. N/A Lot 8170111 Bag serial numbers 68194152 68194153 68194160 68… AMCL05P UDI-DI 191072207296 Lot 7990011 Bag serial no. N/A Lot 8170111 Bag serial numbers 68194152 68194153 68194160 68194176 68194179 68194182 68194190 Lot 8526511 Bag serial numbers 68873157 68874410; EVLH67F UDI-DI 191072232380 Lot 8211011 Bag serial number N/A Lot 8367311 Bag serial number 68570438; FDCL22R UDI-DI 191072185259 Lot 8048511 Bag serial numbers 68045373 68045376; IHCC03X UDI-DI 191072226273 Lot 80111 Bag serial number N/A Lot 8085711 Bag serial numbers 47506640 47506761; TNCC02AD UDI-DI 191072212757 Lot 7970911 Bag serial number N/A Lot 8045911 Bag serial number 47503192 Lot 8426711 Bag serial number 47886615; UICC27AG UDI-DI 191072231307 Lot 8085511 Bag serial number N/A Lot 8167611 Bag serial number 68194108; UIRD89AH UDI-DI 191072231314 Lot 8068111 Bag serial number 47499672 47499908 * if Bag serial number is "n/a", then all of that lot is affected

code_info

AMCL05P UDI-DI 191072207296 Lot 7990011 Bag serial no. N/A Lot 8170111 Bag serial numbers 68194152 68194153 68194160 68…

AMCL05P UDI-DI 191072207296 Lot 7990011 Bag serial no. N/A Lot 8170111 Bag serial numbers 68194152 68194153 68194160 68194176 68194179 68194182 68194190 Lot 8526511 Bag serial numbers 68873157 68874410; EVLH67F UDI-DI 191072232380 Lot 8211011 Bag serial number N/A Lot 8367311 Bag serial number 68570438; FDCL22R UDI-DI 191072185259 Lot 8048511 Bag serial numbers 68045373 68045376; IHCC03X UDI-DI 191072226273 Lot 80111 Bag serial number N/A Lot 8085711 Bag serial numbers 47506640 47506761; TNCC02AD UDI-DI 191072212757 Lot 7970911 Bag serial number N/A Lot 8045911 Bag serial number 47503192 Lot 8426711 Bag serial number 47886615; UICC27AG UDI-DI 191072231307 Lot 8085511 Bag serial number N/A Lot 8167611 Bag serial number 68194108; UIRD89AH UDI-DI 191072231314 Lot 8068111 Bag serial number 47499672 47499908 * if Bag serial number is "n/a", then all of that lot is affected

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0175-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.