High FDA (Devices)·Z-1546-2025·Announced 2025-04-16

Medline ReNewal Coblator II Evac 70 Xtra Plasma Wand Disconnection Risk

Medline Industries is recalling 738 units of the ReNewal Coblator II Evac 70 Xtra Plasma Wand due to risk that drip chambers may disconnect from the saline line tubing under tension.

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 medical device with a structural/functional defect that could compromise intended use. No illnesses or injuries are reported in the source text, but the defect poses a risk of harm if the device disconnects during clinical use.

Plain-English summary

Medline Industries, LP is recalling the ReNewal Coblator II Evac 70 Xtra Plasma Wand with Integrated Saline Line & Integrated Cable (Item Number REF EICA58720R) due to a defect in the device's drip chamber connection. The drip chambers of affected devices may disconnect from the saline line tubing when under tension, which could compromise the device's intended function during use.

This recall affects 738 units that were distributed nationwide in the United States. The affected devices include the following lot numbers: 513468, 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, 520358, 520691, 520692, 521358, 521359, 522140, 522141, 522142, 522143, 522506, 522507, 522508, 522510, 524010, 524011, 524015, 524798, 524801, 524802, 524822, 525470, 525474, 527114, 527117, 528453, 528455, 528583, 528585, 528586, 528896, 528899, 528902, 528903, 528904, 529481, 529491, 529931, 529932, 530010, 530435, 531018, 531025, 531026, 531027, 531672, 532270, 532272, 532815, 532817, 532819, 532822 (UDI/DI 10888277395350).

Customers who have received these devices should discontinue use and contact Medline Industries for further guidance on replacement or return of the affected units.

The recalled product

Product: MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical/Procedural Equipment
Hazard: device-disconnection
saline-line-failure
Affected units: 738

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 10888277395350
Lot Numbers: 513468
513993
514445
514446
514449
515558
515650
515861
515907
516476
516478
516549
517320
517321
517322
517323
517358
517360
517627

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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