MEDLINE Coblator II surgical wand saline tubing disconnection recall
MEDLINE Industries is recalling 315 units of the ReNewal ENT Coblator II PROcise XP Wand due to potential disconnection of drip chambers from saline line tubing when under tension. The defect could affect proper saline delivery during surgical procedures.
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 surgical medical device with a specific mechanical defect that could interfere with proper saline delivery during procedures. Although no illnesses or injuries have been reported, the hazard poses a risk of harm during use, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
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 device is used in ear, nose, and throat surgical procedures. A total of 315 units have been distributed nationwide in this recall.
The drip chambers of affected devices may disconnect from the saline line tubing when under tension. This disconnection could impair the proper delivery of saline solution during the surgical procedure.
The recalled devices are identified by 36 specific lot numbers including 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, and 531676. Customers in possession of devices with these lot numbers should discontinue use and contact the manufacturer for further instructions.
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
- Hazard
- tubing-disconnection
- saline-delivery-failure
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.
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