FDAClass IIOctober 23, 2019

Cautery Tip Cleaner recall: Sterility Concern

Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory

Why was Cautery Tip Cleaner recalled?

The sterile barrier of some devices may have been affected

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 16DEC19 17JAN06 17JAN06A 17JAN23 17FEB27 17MAR13 17MAR13A 17APR03 17APR14 17MAY24 17MAY24A 17MAY24B 17JUN27 17JUL17 17AUG01 17SEP22 17SEP22A 17OCT23 17NOV27 17NOV27A 17DEC15 18JAN19 18JAN19A 18FEB16 18MAR02 18MAR19 18MAR19A ***Updated 11/9/21*** 19MAR14 UDI: Case 20787551000577 and Each 00787551000573

Product
Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory
Recalling firm
Xodus Medical Inc
Quantity
255,000 each
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
Recall date
October 23, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls