Bentson Wire Guide Devices Recalled for Potential Sterility Compromise
Cook Incorporated is recalling Bentson Wire Guide devices due to potential packaging defects that may compromise device sterility.
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 is an FDA Class II medical device recall for potential sterility compromise due to packaging defect. No illnesses or injuries have been reported, and the hazard is preventive in nature, making it at most a score of 3 per the rubric.
Plain-English summary
Cook Incorporated is recalling certain lots of Bentson Wire Guide guidewires (part number TSMB-35-145, GPN G27041). The devices may have a complete breach of the chevron seal in their packaging, which is designed to protect device sterility.
A breach in the chevron seal may compromise the sterility of the affected devices. Bentson Wire Guide devices are used in medical procedures and are regulated by the FDA as Class II medical devices.
The recalled lot is Lot 14797970 with an expiration date of June 16, 2027. These devices have been distributed domestically nationwide and internationally worldwide.
The recalled product
- Product
- Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
- Manufacturer
- Cook Incorporated
- Affected units
- 43
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- TSMB-35-145 (GPN G27041) UDI-DI 00827002270411
- Lot 14797970
- Expiration Date 16-06-2027
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 breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- HighCook Inc. Recalls Bentson PTFE Wire Guides 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
- ModerateCook Inc. Recalls Bentson Wire Guides Due to Missing Heparin Labeling
FDA (Devices) · 2018-03-21
- ModerateCook Inc. Recalls Bentson Plus Wire Guide Due to Labeling Error
FDA (Devices) · 2018-03-21
- HighCook Inc. Recalls Angled Tip Ureteral Catheter Sets Due to Loading Error
FDA (Devices) · 2020-02-12
- HighRoadrunner UniGlide Vascular Wire Guide Recalled for Sterility Compromise
FDA (Devices) · 2022-09-21