Recall archive / FDA device enforcement
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use... — FDA record Z-0796-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 19, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Med Michigan Holding Llc
- Quantity
- 109 boxes (2,180 eaches)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0796-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI 00817278010514 Lot 08294-080724 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product distributed to a distributor located in IL.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 8, 2025
- Recall initiation date
- Nov 19, 2024
- Center classification date
- Dec 31, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.