Reported Oct 22, 2025 · Ongoing
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK…
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 BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 191072235350BUCY78E UDI-DI 191072235350 Lot 8531411 Bag serial number 17705421 2 191072228215CMCP10X UDI-DI 191072228215 Lot 8392411 Bag serial number 17622370 3 191072159922IHCY10Y UDI-DI 191072159922 Lot 8026111 Bag serial number 17499185 Lot 8346211 Bag serial number 17692649 Lot 8444211 Bag serial number 17681124 4 191072228864MHCY35AE UDI-DI 191072228864 Lot 7990511 Bag serial number N/A 5 191072141415PLBY52E UDI-DI 191072141415 Lot 8016811 Bag serial number 17435184 6 00191072213990UDCY31Z UDI-DI 00191072213990 Lot 8043211 Bag serial number 17483121 17483122 17483143 17483144 17485283 7 191072205537UICY28L UDI-DI 191072205537 Lot 8217311 Bag serial number 17598793 * 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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