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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medline Coblator II Plasma Wands Recalled for Tubing Disconnection Risk

Agency Publication Date: April 9, 2025
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Summary

Medline ReNewal is recalling 1,297 Coblator II Plasma Wands and Wands, including the Evac 70 Xtra, ENT Evac 70 Xtra HP, PROcise XP, and PROcise mAx models. Medline has identified that the drip chambers on these surgical devices may disconnect from the saline line tubing when the tubing is under tension or pulled. These devices are primarily used in surgical procedures, and a disconnection could lead to an interruption of saline flow or leakage during a procedure. No injuries or incidents have been reported to date.

Risk

The drip chambers may detach from the saline line during use, potentially causing an interruption in the delivery of saline required for the procedure. This defect could result in surgical delays or leakage of saline in the operating environment.

What You Should Do

  1. This recall affects Medline ReNewal Coblator II Plasma Wands, including Evac 70 Xtra, ENT Evac 70 Xtra HP, PROcise XP, and PROcise mAx models.
  2. Identify affected products by checking the device packaging for item numbers EICA58720R, EICA58740R, EICA88720R, or EICA88980R and the specific lot number printed on the label.
  3. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  5. For additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand, w/Integrated Saline Line & Integrated Cable
Model / REF:
EICA58720R
Lot Numbers (91):
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
UDI:
10888277395350

Recall Number Z-1546-2025.

Product: MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP, w/Integrated Cable (Blue/Grey)
Model / REF:
EICA58740R
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
529932
530010
531025
531027
532815
532817
UDI:
10888277395367

Recall Number Z-1547-2025.

Product: MEDLINE ReNewal ENT Coblator II PROcise XP Wand, w/Integrated Cable Suction & Saline (Blue)
Model / REF:
EICA88720R
Lot Numbers:
506894
509420
512983
513469
514448
514549
515557
515860
515903
516550
517359
517626
519259
519413
519966
520277
521360
522144
522145
525472
527111
527115
527121
528456
528457
528582
529483
529485
529487
529489
529930
530432
530433
530434
531020
531024
531676
UDI:
10888277395374

Recall Number Z-1548-2025.

Product: MEDLINE ReNewal ENT Coblator II PROcise mAx, w/Integrated Cable Suction & Saline (Blue)
Model / REF:
EICA88980R
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
UDI:
10080196415106

Recall Number Z-1549-2025.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96541
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospital supply channels; Medline Industries distribution
Manufactured In: United States
Units Affected: 4 products (738 units; 020 units; 315 units; 224 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.