Recall archive / FDA device enforcement
Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B... — FDA record Z-0183-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 4, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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)
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- American Contract Systems Inc.
- Quantity
- 32,433 total
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0183-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | ANLM40AG UDI-DI 191072232076 Lot 8192111 Bag serial number 68195596; ANPP15AR UDI-DI 191072214423 Lot 8024911 Bag serial number 68055493; HSLM53AB UDI-DI 191072224095 Lot 8061111 Bag serial number 68138767; MILM82A UDI-DI 191072231512 Lot 8361111 Bag serial number 68576542; RCNA47B UDI-DI 191072228536 Lot 8441711 Bag serial number 68680026; SFLM54AB UDI-DI 191072217400 lot 8105511 Bag serial number N/A; UDLM94AA UDI-DI 191072214089 Lot 8382011 Bag serial number 17621919; UILM77AU UDI-DI 191072210333 Lot 8056311 Bag serial number N/A; UINR44P UDI-DI 191072210340 Lot 8067511 Bag serial numbers 68138618 68140374; UISH15AV UDI-DI 191072227843 Lot 8028211 Bag serial number 68154067 * If bag serial number is listed as "N/A", then whole lot is affected |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 22, 2025
- Recall initiation date
- Sep 4, 2025
- Center classification date
- Oct 16, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.