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.
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 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
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 Cautery Tip Cleaners Due to Sterile Barrier Concerns
FDA (Devices) · 2019-10-23
Same hazard · sterile barrier compromise
See all →- HighBARD Dynamic Tip Steerable Reprocessed Electrophysiology Catheter Recall
FDA (Devices) · 2026-05-20
- ModerateDisposable Mixing Bowls with Spatula recalled for compromised sterile barrier
FDA (Devices) · 2026-05-06
- SevereTufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier
FDA (Devices) · 2025-05-21
- HighIntroducer Needle REF NDL-107-04 Sterile Packaging Recall
FDA (Devices) · 2025-05-14
- HighGalt Medical Introducer Kit Coaxial Dilator recalled for packaging seal issue
FDA (Devices) · 2025-05-14
Similar recalls
- HighConMed Recalls Electrosurgical Tip Cleaners Due to Compromised Sterile Seals
FDA (Devices) · 2013-01-30
- SevereExtended Tip Applicator 8CM medical devices recalled due to sterility concerns
FDA (Devices) · 2025-07-02
- HighStradis Healthcare Curved Tip Syringes Recalled Due to Incomplete Sterile Sealing
FDA (Devices) · 2022-12-21
- HighSklar Instruments IUD Extractor Kits Recalled for Sterile Barrier Packaging Issues
FDA (Devices) · 2025-01-22
- HighMedline Iris Scissors Recalled Due to Detachable Tip Protector Risk
FDA (Devices) · 2023-09-27
- SevereExtended Tip Applicator 8CM distributed by Integra LifeSciences recalled nationwide
FDA (Devices) · 2025-07-02