Agency classClass IIOur severity:High FDA (Devices)·Z-1549-2025·Announced 2025-04-16

Medline ReNewal ENT Coblator II Suction Device Drip Chamber Disconnection

Medline ReNewal is recalling 224 units of ENT Coblator II PROcise mAx devices because the drip chambers may disconnect from the saline line tubing under tension, creating a potential surgical hazard.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a structural/functional defect (drip chamber disconnection) that poses a risk of harm during surgical procedures. Although no injuries have been reported in the source text, the recall addresses a risk-of-harm condition in a critical-use device, meeting the High severity threshold.

Plain-English summary

Medline ReNewal has identified that the drip chambers of affected MEDLINE ReNewal ENT Coblator II PROcise mAx devices (Item Number REF EICA88980R, UDI/DI 10080196415106) may disconnect from the saline line tubing when under tension. This disconnection could affect proper delivery of saline during use.

The recalled devices were distributed nationwide in the United States. The recall involves 224 units across 29 specific 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, and 531022.

If you have one of these devices, contact Medline Industries, LP for further instructions. Do not use affected units until receiving guidance from the manufacturer.

The recalled product

Product: MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical / ENT Equipment
Hazard: device-disconnection
saline-delivery-failure
Affected units: 224

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI/DI 10080196415106
Lot Numbers: 506549
508766
509420
512036
512983
514060
514709
516475
516802
517626
518478
518961
519248
519259
519411
519412
519413
519966
519969

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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