CLASS II ONGOING Device recall · Reported 16 Apr 2025 · FDA Enforcement Report

Medline ReNewal ENT Coblator II PROcise mAx,W/ Integrated recalled

Medline Industries LP - Northfield is recalling Medline ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), distributed nationwide in the US. The recall was initiated on 5 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 10080196415106, Lot Numbers: 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.

Quantity recalled224 units

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-1549-2025
FDA event ID: 96541
Recalling firm: Medline Industries LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 5 Mar 2025
FDA classified: 9 Apr 2025
Reported: 16 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Mar 2025	Recall initiated by company
9 Apr 2025	Classified by FDA	+35 days
16 Apr 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

Product as listed by the FDA

MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R

Where it was distributed

US Nationwide distribution

Nationwide

Questions about this recall

Why was it recalled?

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

Which lots are affected?

UDI/DI 10080196415106, Lot Numbers: 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.

Where was it sold?

US Nationwide distribution

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.

Other products in this recall event

3 other products · FDA event 96541

This product is part of a recall event; the main page for the event is Medline ReNewal ENT Coblator II PROcise XP recalled.

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025	CLASS II	Medline ReNewal ENT Coblator II PROcise XP recalled	Medline Industries LP - Northfield	Other	Nationwide
16 Apr 2025	CLASS II	Medline ReNewal Coblator II ENT Evac 70 Xtra recalled	Medline Industries LP - Northfield	Other	Nationwide
16 Apr 2025	CLASS II	Medline ReNewal Coblator II Evac 70 Xtra Plasma recalled	Medline Industries LP - Northfield	Other	Nationwide

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