SUC-4300S — Class II medical device recall Z-0796-2025
Ongoing recall by Med Michigan Holding Llc, reported 2025-01-08, distributed in IL. Incomplete or partial pouch seals, which may result in a breach in the sterility.
| Recall number | Z-0796-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Med Michigan Holding Llc, Walker, MI, United States |
| Recall initiated | 2024-11-19 |
| Classified | 2024-12-31 |
| Reported by FDA | 2025-01-08 |
| Distributed | IL |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00817278010514 |
| Lot numbers | 08294-080724 |
Product
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.
Reason for recall
Incomplete or partial pouch seals, which may result in a breach in the 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-0796-2025. 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.