Medline recalls ENT devices with serial numbers 513993-532817 that may disconnect under tension, risking fluid leaks during surgery.
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Medline is recalling ENT surgical devices that could disconnect from saline tubing when pulled. This might cause fluid leaks during procedures, potentially affecting patient safety.
The drip chambers in these devices may detach from the saline tubing when pulled or stressed. This could lead to fluid leaks during surgery, potentially causing complications for patients.
Surgical staff using Medline ReNewal Coblator II ENT Evac 70 Xtra HP devices with specific serial numbers are affected. Patients undergoing ENT surgery with these devices face the highest risk.
Check for the model name 'ReNewal Coblator II ENT Evac 70 Xtra HP' with blue or grey color and integrated cable. Look for serial numbers listed in the recall notice: 513993 to 532817.
Verify your device's serial number against the list: 513993, 514445, 514446, and other numbers provided in the recall notice.
Reach out to Medline directly to confirm if your device is affected and get instructions for next steps.
The drip chambers may disconnect from the saline line tubing when under tension, which could lead to fluid leaks during surgery.
Check your device's serial number against the list provided in the recall notice. Contact Medline for further instructions.
The device may disconnect under tension, so it's recommended to check the serial number and contact Medline before use.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1547-2025 — Medline Medline Hello, I own a Medline that is covered by recall Z-1547-2025 from Medline. 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.
