Data Foundry

Medical device recalls 2022

1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack — Class II medical device recall Z-1037-2022

Ongoing recall by American Contract Systems, Inc., reported 2022-05-18, distributed nationwide. Product was sterilized with a higher than specification EO concentration.

Recall numberZ-1037-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAmerican Contract Systems, Inc., Kansas City, MO, United States
Recall initiated2022-03-22
Classified2022-05-06
Reported by FDA2022-05-18
DistributedNationwide (US)
Quantity114 packages
UPC / GTIN / UDI-DI00191072149954, 00191072150158, 00191072152978
Lot numbers966221, 981221
Model numbersFHHP63T, LMAR15R, LWKN46N

Product

1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack

Reason for recall

Product was sterilized with a higher than specification EO concentration.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1037-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.