Med Michigan recalls SUC-4300S surgical suction devices due to potential pouch seal breaches causing sterility loss. Affected units have specific UDI-DI and lot numbers.
Incomplete or partial pouch seals, which may result in a breach in the sterility.
Med Michigan is recalling its SUC-4300S rigid intracardiac sucker devices because pouch seals may not close properly, risking contamination during surgery. This could lead to infections if the device isn't sterile when used.
The device's pouch seals may not close completely, allowing bacteria to enter the sterile field. This could compromise surgical sterility if the device is used without proper sealing.
Surgical staff and hospitals using the SUC-4300S devices with UDI-DI 00817278010514 and lot numbers 08294-080724 are most at risk. These devices are designed for handheld use during surgery.
Check for the model SUC-4300S with a 1/4" (6.4mm) connector and 13" (33cm) length. The UDI-DI number 00817278010514 and lot numbers 08294-080724 identify affected units.
Verify the UDI-DI number 00817278010514 and lot numbers 08294-080724 on the device label.
The pouch seals may not close properly, risking contamination during surgery if the device isn't sterile.
Check the UDI-DI number and lot numbers on the device label to confirm if it's affected. If it is, contact Med Michigan for guidance.
The device is safe for use if the pouch seals are intact and the UDI-DI and lot numbers match the recalled units. Otherwise, it may not be sterile.
We’ve drafted a message you can send Med Michigan to request your refund or repair — edit it as you like.
Subject: Recall Z-0796-2025 — Med Michigan Med Michigan Hello, I own a Med Michigan that is covered by recall Z-0796-2025 from Med Michigan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
