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.
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 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
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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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