Z-0149-2020Class II

Electrosurgical Tip Cleaner REF: 138029

Name: Z-0149-2020 Electrosurgical Tip Cleaner REF: 138029
Creator: Xodus Medical Inc
Published: 2019-09-19
License: https://open.fda.gov/license/

Xodus Medical Inc / initiated 2019-09-19 / Terminated / root cause: packaging

FDA source

Xodus Medical Inc began a recall of Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory on 2019-09-19. FDA classified it as Class II and gives the reason as "The sterile barrier of some devices may have been affected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0149-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-19
Posted: 2019-10-16
Terminated: 2024-03-04
Recalling firm: Xodus Medical Inc
Product: Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The sterile barrier of some devices may have been affected
Root cause tag: packaging
FDA root cause: Packaging
Action: Urgent Medical Device Voluntary Recall notification letters dated 9/20/19 were sent to customers. An Urgent Medical Device Voluntary Recall REVISED RECALL NOTICE notification letters were sent to customers on 9/27/19. 1. Immediately check your inventory and quarantine affected stock on hand. 2. The following process shall be undertaken in order to segregate any affected inventory. The existing inventory shall be inspected and any affected product quarantined and destroyed. A. Inspect the Tyvek pouch seal integrity. B. Secondly, the product contained within the pouch may be partially sealed into the Tyvek seal itself. 3. unaffected product shall be distributed with no futher action necessary. 4. For any product that is quarantined and must be destroyed: A. Xodus Medical requires documentation of the affected inventory that is found to be affected and destroyed. Information regarding the following shall be documented and provided to Xodus Medical. B. Product Number; Quantity Affected; Method of Destruction; Evidence of Destruction. It can be photos or videos of product being destroyed 5. Please immediately complete the attached Acknowledgement form even if you do not have any affected stock, and return the acknowledgement to Xodus Medical at the following: Email [email protected] or Fax +1 724-337-1131 For further information and question, please call Paul Lloyd, Vice President, Global QA/RA & Technology, Xodus Medical; +1 724-337-5500; [email protected] Urgent: Medical Device Voluntary Recall REVISED RECALL NOTICE dated 6/8/20 were sent to customers. Xodus Medical has received complaints of some devices where the sterile barrier of some devices may have been affected. Xodus Medical has confirmed instances where the pouch seal was compromised on some of the reported product. In no instance has it been reported to Xodus Medical that a compromise in the sterile barrier has resul
Quantity in commerce: 464,040 eaches
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0149-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0149-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-23	2019-10-16
Z-0150-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-23	2019-10-16
Z-0151-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-23	2019-10-16

Product code GEI

K053433Class IICautery Tip Cleaner, Model 30500Xodus Medical, Inc. / cleared 2006-01-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)