Xodus Medical Recalls Electrosurgical Tip Cleaners Due to Sterile Barrier Concerns
Xodus Medical Inc is recalling 460,000 Electrosurgical Tip Cleaners because the sterile barrier of some devices may have been affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 potential breach of the sterile barrier for a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Xodus Medical Inc is recalling 460,000 units of Electrosurgical Tip Cleaners (REF: 62-8499-001). The recall was initiated because the sterile barrier of some devices may have been affected.
The affected products are electrosurgical accessories distributed worldwide, including in the United States and various international locations. Specific lot numbers and UDI codes are listed in the agency's recall record.
Healthcare providers and consumers should stop using the affected devices and contact Xodus Medical Inc for further instructions or a replacement.
The recalled product
- Product
- Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
- Manufacturer
- Xodus Medical Inc
- Affected units
- 460,000
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
Same manufacturer · Xodus Medical Inc
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FDA (Devices) · 2019-10-23
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FDA (Devices) · 2019-10-23
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