Z-1549-2025Class II

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

Name: Z-1549-2025 MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-03-05
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-03-05 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R on 2025-03-05. FDA classified it as Class II and gives the reason as "Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1549-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-05
Posted: 2025-04-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
FDA root cause: Under Investigation by firm
Action: Medline issued a "Medline ReNewal IMMEDIATE ACTION REQUIRED" notice dated 3/5/2025, to its consignees on 03/05/2025 via USPS first class mail. The notice explained the issue, potential risk, and requested the following actions: REQUIRED ACTION: 1. Immediately check your stock for the affected item numbers and the affected lot numbers. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Upon receipt of your submitted response form, FedEx return label(s) will be provided. Even if you do not have any affected product, please complete and return the form, as indicated on the response form. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline ReNewal. For questions, please contact 866-359-1704 or [email protected].
Quantity in commerce: 224 units
Distribution: US Nationwide distribution
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1549-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1546-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-09
Z-1547-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-09
Z-1548-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-09
Z-1549-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-09

Product code GEI

K012669Class IIReprocessed Electrosurgical ElectrodesSurgical Instruments Service and Savings, Inc. / cleared 2002-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)