Reported Oct 22, 2025 · Ongoing
Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE…
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 RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 191072234360FHGY09S UDI-DI 191072234360 lot 8532011 bag serial number 68874879 2 191072209337LMGY39U UDI-DI 191072209337 Lot 8490211 bag serial numbers 47860009 47861175 3 191072236555OWGY11Q UDI-DI 191072236555 lot 8389711 bag serial number 17622382 4 191072232670RCGY52D UDI-DI 191072232670 lot 8142411 bag serial number 17487909 5 191072106674UIGN82M UDI-DI 191072106674 lot 8084811 bag serial numbers 17391081 17391091 17391111 17391171 lot 8445711 bag serial numbers 17683242 lot 8530511 bag serial numbers 17712404 6 00191072234117UIHY16AE UDI-DI 00191072234117 Lot 8171811 N/A * If bag serial number is listed as "n/a", then entire 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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