The Recall Desk
HighFDA (Devices)·Z-1548-2025·Announced 2025-04-16

Medline ReNewal ENT Coblator II PROcise XP Wand recalled

Medline has recalled 315 units of the ReNewal ENT Coblator II PROcise XP Wand nationwide because the drip chamber may disconnect from the saline line tubing under tension.

What this means for you

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 recall of a medical device where a structural/functional defect (disconnection of drip chamber) poses a risk of harm, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Medline Industries, LP is recalling the ReNewal ENT Coblator II PROcise XP Wand with Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R. The drip chambers of affected devices may disconnect from the saline line tubing when under tension, creating a potential hazard during use.

A total of 315 units have been distributed nationwide. The affected lot numbers are: 506894, 509420, 512983, 513469, 514448, 514549, 515557, 515860, 515903, 516550, 517359, 517626, 519259, 519413, 519966, 520277, 521360, 522144, 522145, 525472, 527111, 527115, 527121, 528456, 528457, 528582, 529483, 529485, 529487, 529489, 529930, 530432, 530433, 530434, 531020, 531024, 531676. The UDI/DI is 10888277395374.

Patients and healthcare providers who have this device should contact Medline Industries, LP for further instructions on how to proceed.

The recalled product

Product
MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — ENT / Surgical Wand
Hazard
Affected units
315

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 10888277395374
  • Lot Numbers: 506894
  • 509420
  • 512983
  • 513469
  • 514448
  • 514549
  • 515557
  • 515860
  • 515903
  • 516550
  • 517359
  • 517626
  • 519259
  • 519413
  • 519966
  • 520277
  • 521360
  • 522144
  • 522145

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 →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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