FDA recall Z-0185-2026

American Contract Systems Inc. · Class II · device

Product

Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY50AC EYE PACK-206026 UIVT47AS VITRECTOMY SUPPLY

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.

Distribution

US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Key facts

Status: Ongoing
Initiation date: 2025-09-04
Report date: 2025-10-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Grimes, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0185-2026