ACS IR — Class II medical device recall Z-1038-2022
Ongoing recall by American Contract Systems, Inc., reported 2022-05-18, distributed nationwide. Product was sterilized with a higher than specification EO concentration.
| Recall number | Z-1038-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Contract Systems, Inc., Kansas City, MO, United States |
| Recall initiated | 2022-03-22 |
| Classified | 2022-05-06 |
| Reported by FDA | 2022-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 24 packages |
| UPC / GTIN / UDI-DI | 00191072151612 |
| Lot numbers | 657211 |
| Model numbers | JEIR37H |
Product
ACS IR - Angio 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-1038-2022. 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.