Xodus Medical Recalls Electrosurgical Tip Cleaners Due to Sterile Barrier Concerns
Xodus Medical Inc is recalling 464,040 Electrosurgical Tip Cleaners because the sterile barrier of some devices may have been affected.
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: The recall involves a medical device where the sterile barrier may be compromised, posing a risk of infection. No specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Xodus Medical Inc is recalling 464,040 units of Electrosurgical Tip Cleaners (REF: 138029). The recall was initiated because the sterile barrier of some devices may have been affected.
The affected products were distributed worldwide, including in the United States and in countries such as Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, and Mexico. Specific lot numbers and UDI codes are listed in the recall documentation.
Healthcare providers and consumers should stop using the affected products and contact Xodus Medical Inc for instructions on return or replacement.
The recalled product
- Product
- Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory
- Manufacturer
- Xodus Medical Inc
- Affected units
- 464,040
Distribution
Part of a larger recall action
This product is one of 3 recalled by Xodus Medical Inc 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 3 products in this recall →Related recalls
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