FDA Device recall Z-0796-2025
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip
- FDA Device
- Class II
- ongoing
- Published 2025-01-08
On 2025-01-08 the FDA classified a Class II recall of SUC-4300S, Rigid Intracardiac Sucker Fluted Tip by Med Michigan Holding, citing incomplete or partial pouch seals, which may result in a breach in the sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0796-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-19 |
| Published | 2025-01-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Med Michigan Holding |
| Distribution | IL |
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
Incomplete or partial pouch seals, which may result in a breach in the sterility.
Identifiers
| code_info | UDI-DI 00817278010514 Lot 08294-080724 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0796-2025%22
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