Medline Renewal recalls ENT Coblator II ProCise Max devices with specific lot numbers due to risk of drip chambers disconnecting from saline tubing when under tension.
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Medline Renewal is recalling ENT Coblator II ProCise Max devices with certain lot numbers because the drip chambers might disconnect from the saline line tubing when under tension. This could lead to improper saline flow during procedures.
The drip chambers in affected devices can disconnect from the saline line tubing when the device is under tension, such as during normal use. This could cause improper saline flow during medical procedures, potentially leading to complications.
Medical professionals using ENT Coblator II ProCise Max devices with the listed lot numbers are most at risk. Patients undergoing procedures with these devices may also be affected.
Check the lot numbers on the device: 506549, 508766, 509420, 512036, 512983, 514060, 514709, 516475, 516802, 517626, 518478, 518961, 519248, 519259, 519411, 519412, 519413, 519966, 519969, 520277, 522144, 522145, 527110, 527112, 528454, 528458, 528584, 531021, 531022.
Look for the lot numbers listed: 506549, 508766, 509420, 512036, 512983, 514060, 514709, 516475, 516802, 517626, 518478, 518961, 519248, 519259, 519411, 519412, 519413, 519966, 519969, 520277, 522144, 522145, 527110, 527112, 528454, 528458, 528584, 531021, 531022.
The drip chambers may disconnect from the saline line tubing when the device is under tension, which could cause improper saline flow during procedures.
Check the lot numbers on the device: 506549, 508766, 509420, 512036, 512983, 514060, 514709, 516475, 516802, 517626, 518478, 518961, 519248, 519259, 519411, 519412, 519413, 519966, 519969, 520277, 522144, 522145, 527110, 527112, 528454, 528458, 528584, 531021, 531022.
No, but you should check the lot numbers to see if your device is affected. If it is, you may need to take action to prevent disconnection.
We’ve drafted a message you can send Medline Renewal to request your refund or repair — edit it as you like.
Subject: Recall Z-1549-2025 — Medline Renewal Medline Renewal Hello, I own a Medline Renewal that is covered by recall Z-1549-2025 from Medline Renewal. 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.
