Class II — Med Michigan Holding Llc
| Recalling firm | MED Michigan Holdings LLC |
|---|---|
| Registered facility | MED MICHIGAN HOLDINGS LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Incomplete or partial pouch seals, which may result in a breach in the sterility. |
| 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. |
| Quantity | 109 boxes (2,180 eaches) |
| Distribution | Product distributed to a distributor located in IL. |
| Initiated | 2024-11-19 |
| Classified | 2024-12-31 |
| Recall number | Z-0796-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Med Michigan Holding Llc (Z-0796-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95889/
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