ENT — Class II medical device recall Z-3241-2024
Ongoing recall by American Contract Systems, Inc., reported 2024-10-02, distributed nationwide. ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of
| Recall number | Z-3241-2024 |
|---|---|
| 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 | 2024-08-07 |
| Classified | 2024-09-24 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 66 units |
| UPC / GTIN / UDI-DI | 00191072206244 |
| Lot numbers | 2405092 |
| Expiration dates | 2025-05-09 |
Product
ENT, COEN27N; Medical convenience kit
Reason for recall
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
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-3241-2024. 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.