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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

American Contract Systems, Inc.: Product was sterilized with a higher than specification EO concentration.

Agency Publication Date: May 6, 2022
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Affected Products

Product: 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray

1) ACS Spine Pack - Model LOSP35D, Lot 966221; UDI 00191072154613 2) ACS Lumbar/Back Set Up Tray - Model SALB85AG, Lot 973221; UDI: 00191072127280

Lot Numbers:
966221
973221
Product: 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack

1) ACS Arthroscopy Kit - Model LMAR15R, Lot 981221; UDI: 00191072152978 2) ACS Knee Kit - Model LWKN46N, Lot 966221; UDI: 00191072150158 3) ACS Hand Pack - Model FHHP63T, Lot 966221, UDI: 00191072149954

Lot Numbers:
981221
966221
966221
Product: ACS IR - Angio Pack

Model JEIR37H, Lot 657211 UDI: 00191072151612

Lot Numbers:
657211
Product: ACS Lap Chole Pack

Model BLLC42M, Lot 643211 UDI: 00191072152473

Lot Numbers:
643211
Product: ACS Cath Lab Pack

Model FTCL83K, Lot 982221 UDI: 00191072151360

Lot Numbers:
982221

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89868
Status: Active
Manufacturer: American Contract Systems, Inc.
Manufactured In: United States
Units Affected: 5 products (72 packs; 114 packs; 24 packs; 20 packs; 10 packs)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.