MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP — Class II medical device recall Z-1547-2025

Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-16, distributed nationwide. Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line

Recall number	`Z-1547-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated	2025-03-05
Classified	2025-04-09
Reported by FDA	2025-04-16
Distributed	Nationwide (US)
Quantity	20 units
UPC / GTIN / UDI-DI	`10888277395367`
Lot numbers	`513993`, `514445`, `514446`, `514449`, `515558`, `515650`, `515861`, `515902`, `515907`, `516478`, `516549`, `517320`, `518476`, `519258`, `519265`, `519678`, `519759`, `519760`, `520279`, `520282`, `520357`, `520692`, `521356`, `521359`, `522140`, `522141`, `522143`, `522507`, `522508`, `524010`, `524011`, `524015`, `524797`, `524798`, `524802`, `528455`, `528586`, `528587`, `528896`, `528904` and 6 more
Model numbers	`EICA58740R`

Product

MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1547-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.