Various Pacemaker Packs — Class II medical device recall Z-1691-2022
Ongoing recall by American Contract Systems, Inc., reported 2022-09-14, distributed in AZ, FL, IA, IL, MA, MN, MO, NE…. Product was exposed to multiple sterilization cycles without validation for multiple exposures.
| Recall number | Z-1691-2022 |
|---|---|
| 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 | 2022-06-16 |
| Classified | 2022-09-08 |
| Reported by FDA | 2022-09-14 |
| Distributed | AZ, FL, IA, IL, MA, MN, MO, NE, OH, PA, RI, SD, TX |
| Quantity | 24 units |
Product
Various Pacemaker Packs, Cardio Thoracic Packs
Reason for recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
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-1691-2022. 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.