Data Foundry

Medical device recalls 2025

MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand — Class II medical device recall Z-1546-2025

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 numberZ-1546-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated2025-03-05
Classified2025-04-09
Reported by FDA2025-04-16
DistributedNationwide (US)
Quantity738 units
UPC / GTIN / UDI-DI10888277395350
Lot numbers513468, 513993, 514445, 514446, 514449, 515558, 515650, 515861, 515907, 516476, 516478, 516549, 517320, 517321, 517322, 517323, 517358, 517360, 517627, 517628, 517631, 518473, 518476, 518477, 518960, 519256, 519257, 519258, 519260, 519264, 519265, 519678, 519759, 519760, 519762, 519860, 519965, 519967, 520279, 520357 and 51 more
Model numbersEICA58720R

Product

MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R

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-1546-2025. 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.