Reported Oct 22, 2025 · Ongoing
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE…
American Contract Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems Inc. · 1601 Se Gateway Dr Ste 120 · Grimes, IA · 50111-5223
Is this the product you have?
- 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
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 191072225955BFCT04X UDI-DI 191072225955 Lot 7992111 bag serial number N/A 2 191072211514CMEY17AI UDI-DI 191072211514 lot 8082511 bag serial numbers 17390960 17390970 17391031 3 191072199720PERP25AQ UDI-DI 191072199720 lot 8078511 bag serial number 17507000 4 191072202918RFEY50AC UDI-DI 191072202918 lot 8048811 bag serial number 17483686 5 191072224569UIVT47AS UDI-DI 191072224569 lot 7969711 bag serial number N/A * If bag serial number is listed as "N/A", then whole lot is affected - Amount recalled
- 32,433 total
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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