Bentson Wire Guide Recalled for Packaging Defect Affecting Sterility
Cook Incorporated is recalling Bentson Wire Guide guidewires due to packaging seal failures that may compromise sterility. The recall affects over 5,500 units distributed in the U.S. and internationally.
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: This Class II medical device recall involves an identified packaging seal defect that may compromise sterility. While no illnesses or injuries have been reported, the potential for infection from non-sterile guidewires used in vascular procedures represents a risk-of-harm scenario meeting the criteria for High (score 3) severity per the rubric.
Plain-English summary
Cook Incorporated is recalling Bentson Wire Guide (20cm Distal Flexibility with Softened Tip) guidewires due to a packaging defect. Cook Medical identified that certain device lots may have a complete breach of the chevron seal in the packaging, which may compromise the sterility of the affected devices.
The recall encompasses approximately 5,571 units distributed within the United States and 409 units distributed outside the United States. Multiple product configurations and lot numbers are affected, with expiration dates ranging through July 2027.
Additional information, including specific affected lot numbers, product codes, and manufacturer guidance, is available through the FDA's official recall documentation.
The recalled product
- Product
- Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
- Manufacturer
- Cook Incorporated
- Category
- Medical Device — Guidewire
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Cook Incorporated 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 24 products in this recall →Related recalls
Same manufacturer · Cook Incorporated
See all →- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- CriticalAurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
- SevereBeacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
- CriticalCook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
- HighCook Medical CTO-18 wire guides labeled with overstated expiration dates
FDA (Devices) · 2026-04-15
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighCook Inc. Recalls Bentson PTFE Wire Guides Due to Loading Error
FDA (Devices) · 2020-02-12
- ModerateCook Inc. Recalls Bentson Wire Guides Due to Missing Heparin Labeling
FDA (Devices) · 2018-03-21
- HighCook Inc. Recalls Angled Tip Ureteral Catheter Sets Due to Loading Error
FDA (Devices) · 2020-02-12
- ModerateCook Inc. Recalls Bentson Cerebral Wire Guide Due to Labeling Error
FDA (Devices) · 2018-03-21
- HighCook Inc. Recalls Wire Guide Due to Incorrect Loading Risk
FDA (Devices) · 2020-02-12
- HighCook Inc. Recalls PTFE Wire Guides Due to Loading Error Risk
FDA (Devices) · 2020-02-12