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

Medline ReNewal Coblator II ENT Evac 70 Xtra recalled

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number, 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 10888277395367, Lot Numbers: 513993, 514445, 514446, 514449, 515558, 515650, 515861, 515902, 515907, 516478, 516549, 517320, 518476, 519258, 519265, 519678, 519759, 519760, 520279, 520282, 520357, 520692, 521356, 521359, 522140, 522141, 522143, 522507, 522508, 524010, 524011, 524015, 524797, 524798, 524802, 528455, 528586, 528587, 528896, 528904, 529932, 530010, 531025, 531027, 532815, 532817.

Quantity recalled020 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-1547-2025
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 Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R

Where it was distributed

US Nationwide distribution

Nationwide

Questions about this recall

Is Medline ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number on 5 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1547-2025.

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 10888277395367, Lot Numbers: 513993, 514445, 514446, 514449, 515558, 515650, 515861, 515902, 515907, 516478, 516549, 517320, 518476, 519258, 519265, 519678, 519759, 519760, 520279, 520282, 520357, 520692, 521356, 521359, 522140, 522141, 522143, 522507, 522508, 524010, 524011, 524015, 524797, 524798, 524802, 528455, 528586, 528587, 528896, 528904, 529932, 530010, 531025, 531027, 532815, 532817.

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 21 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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