FDA Medical devices recall ·
Medical convenience kits Item Number/Description HSLM53AB SPINE PACK… recall
- Recall number
- Z-0183-2026
- Date
- (initiated September 4, 2025)
- Company / brand
- American Contract Systems Inc
1601 Se Gateway Dr Ste 120, Grimes, IA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 32,433 total
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
States: Iowa Illinois Minnesota South Dakota Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0183-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.