Reported Oct 22, 2025 · Ongoing
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY 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 LKRA40G RADIOLOGY PACK
- Lot codes and dates
- LKRA40G UDI-DI 191072189691 Lot 8025211 Bag serial number 68154347 * 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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