Reported Oct 22, 2025 · Ongoing
Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B…
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 HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL (PS 64405) UISH15AV SHUNT PACK (PS 039360)
- Lot codes and dates
10 of 10 products
Products covered by this recall # Barcodes Product as published 1 191072232076ANLM40AG UDI-DI 191072232076 Lot 8192111 Bag serial number 68195596 2 191072214423ANPP15AR UDI-DI 191072214423 Lot 8024911 Bag serial number 68055493 3 191072224095HSLM53AB UDI-DI 191072224095 Lot 8061111 Bag serial number 68138767 4 191072231512MILM82A UDI-DI 191072231512 Lot 8361111 Bag serial number 68576542 5 191072228536RCNA47B UDI-DI 191072228536 Lot 8441711 Bag serial number 68680026 6 191072217400SFLM54AB UDI-DI 191072217400 lot 8105511 Bag serial number N/A 7 191072214089UDLM94AA UDI-DI 191072214089 Lot 8382011 Bag serial number 17621919 8 191072210333UILM77AU UDI-DI 191072210333 Lot 8056311 Bag serial number N/A 9 191072210340UINR44P UDI-DI 191072210340 Lot 8067511 Bag serial numbers 68138618 68140374 10 191072227843UISH15AV UDI-DI 191072227843 Lot 8028211 Bag serial number 68154067 * 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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