OPEN HEART ADULT — Class II medical device recall Z-1339-2025
Ongoing recall by American Contract Systems Inc, reported 2025-03-26, distributed nationwide. ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of funct
| Recall number | Z-1339-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Contract Systems Inc, Tiffin, OH, United States |
| Recall initiated | 2025-02-06 |
| Classified | 2025-03-14 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 90 kits |
| UPC / GTIN / UDI-DI | 00191072219251 |
| Lot numbers | 70-050704, 70-051731, 898241 |
| Model numbers | LLOH01I, LLOH01I-01 |
Product
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Reason for recall
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
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-1339-2025. 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.