Recall Z-1549-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1549-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-05

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-03-05. It names one FDA 510(k) clearance: K012669. Product: MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R. Reason: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2025-03-05
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K012669 — REPROCESSED ELECTROSURGICAL ELECTRODESSurgical Instruments Service and Savings, Inc.·cleared 2002-06-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R

Reason for recall

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

Data sourced from openFDA. This site is unofficial and independent of the FDA.