CLASS II ONGOING Device recall · Reported 8 Jan 2025 · FDA Enforcement Report
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip recalled
Med Michigan Holding is recalling SUC-4300S, Rigid Intracardiac Sucker Fluted Tip, distributed in Illinois. The recall was initiated on 19 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0796-2025
- FDA event ID
- 95889
- Recalling firm
- Med Michigan Holding, Walker, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Nov 2024
- FDA classified
- 31 Dec 2024
- Reported
- 8 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 19 Nov 2024 | Recall initiated by company | |
| 31 Dec 2024 | Classified by FDA | +42 days |
| 8 Jan 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incomplete or partial pouch seals, which may result in a breach in the sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Product distributed to a distributor located in IL.
Questions about this recall
Why was it recalled?
Incomplete or partial pouch seals, which may result in a breach in the sterility.
Which lots are affected?
UDI-DI 00817278010514 Lot 08294-080724
Where was it sold?
Product distributed to a distributor located in IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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