Xodus Medical Recalls Cautery Tip Cleaners Due to Sterile Barrier Concerns
Xodus Medical Inc is recalling 255,000 Cautery 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 is classified as FDA Class II and involves a potential breach of the sterile barrier, which poses a risk of harm (infection) even though specific injuries are not reported in the source text.
Plain-English summary
Xodus Medical Inc is recalling 255,000 units of Cautery Tip Cleaners (REF: 30500). These products are electrosurgical accessories used in medical settings. 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 various international locations. Specific lot numbers and UDI codes are listed in the official recall documentation. The agency has classified this recall as Class II.
Healthcare providers and consumers should stop using the affected Cautery Tip Cleaners and contact Xodus Medical Inc for further instructions on how to return or replace the products.
The recalled product
- Product
- Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory
- Manufacturer
- Xodus Medical Inc
- Affected units
- 255,000
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
See all →- HighXodus Medical Recalls Electrosurgical Tip Cleaners Due to Sterile Barrier Concerns
FDA (Devices) · 2019-10-23
- HighXodus Medical Recalls Electrosurgical Tip Cleaners Due to Sterile Barrier Concerns
FDA (Devices) · 2019-10-23
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