CLASS II Device recall · Reported 23 Oct 2019 · FDA Enforcement Report

Electrosurgical Tip Cleaner recalled by Xodus Medical

Xodus Medical is recalling Electrosurgical Tip Cleaner, distributed nationwide in the US. The recall was initiated on 19 Sep 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 17NOV27 17DEC08 17DEC08A 17DEC15 17DEC15A 18JAN05 18JAN05A 18JAN19 18FEB02 18FEB02A 18FEB16 18MAR02 18MAR19 UDI: Case 20787551000539 and Each - 00787551000535 Additional lots as of 6/8/20: 18JUL27 18JUL27A 18SEP12 18MAY11 18APR09 18OCT03 18MAY01 18NOV21 18NOV21A Additional lots as of 9/9/2021: 18DEC05 19JAN16 19JAN30 19FEB13 19FEB27 19MAR14 19MAR14A 19MAR29

Quantity recalled464,040 eaches

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0149-2020
FDA event ID: 83819
Recalling firm: Xodus Medical, New Kensington, PA
Classification: Class II
Status: Terminated
Recall initiated: 19 Sep 2019
FDA classified: 16 Oct 2019
Reported: 23 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

19 Sep 2019	Recall initiated by company
16 Oct 2019	Classified by FDA	+27 days
23 Oct 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The sterile barrier of some devices may have been affected

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory

Where it was distributed

Worldwide Distribution - US Nationwide in the States of : CA, ID, IL, LA, MD, NY, OH, OK, TX, VA, WI and OUS: Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, Mexico

Nationwide California Idaho Illinois Louisiana Maryland New York Ohio Oklahoma Texas Virginia Wisconsin

Questions about this recall

Is Electrosurgical Tip Cleaner recalled?

Yes. Xodus Medical recalled Electrosurgical Tip Cleaner on 19 Sep 2019. The recall is Class II and its status is Terminated. Recall number Z-0149-2020.

Why was it recalled?

The sterile barrier of some devices may have been affected

Which lots are affected?

Lot # 17NOV27 17DEC08 17DEC08A 17DEC15 17DEC15A 18JAN05 18JAN05A 18JAN19 18FEB02 18FEB02A 18FEB16 18MAR02 18MAR19 UDI: Case 20787551000539 and Each - 00787551000535 Additional lots as of 6/8/20: 18JUL27 18JUL27A 18SEP12 18MAY11 18APR09 18OCT03 18MAY01 18NOV21 18NOV21A Additional lots as of 9/9/2021: 18DEC05 19JAN16 19JAN30 19FEB13 19FEB27 19MAR14 19MAR14A 19MAR29

Where was it sold?

Worldwide Distribution - US Nationwide in the States of : CA, ID, IL, LA, MD, NY, OH, OK, TX, VA, WI and OUS: Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, Mexico

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Xodus Medical

All 3

Reported	Class	Recall	Company	Reason	Where
23 Oct 2019Device	CLASS II	Electrosurgical Tip Cleaner recalled by Xodus Medical	Xodus Medical	Sterility	Nationwide
23 Oct 2019Device	CLASS II	Cautery Tip Cleaner recalled by Xodus Medical	Xodus Medical	Sterility	Nationwide

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