American Contract Systems Laparoscopy Litho Std Pack convenience kit… — Class II medical device recall Z-2519-2024
Ongoing recall by American Contract Systems, Inc., reported 2024-08-14, distributed nationwide. Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the sam
| Recall number | Z-2519-2024 |
|---|---|
| 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 | 2024-05-06 |
| Classified | 2024-08-07 |
| Reported by FDA | 2024-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 120 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00191072190536 |
| Lot numbers | 981241 |
| Expiration dates | 2025-01-19 |
Product
American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
Reason for recall
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
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-2519-2024. 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.