Cook Movable Core Wire Guide Guidewires Recall Due to Packaging Defect
Cook Incorporated is recalling specific lots of Movable Core Wire Guide guidewires due to a potential breach of the packaging seal 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: FDA Class II device with potential sterility compromise due to packaging seal defect. No illnesses or injuries have been reported. This meets the criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Cook Incorporated has recalled specific lots of Movable Core Wire Guide (Tapered Tefcor) guidewires due to a potential packaging defect. The company identified that the packaging seal—specifically the chevron seal—may be completely breached. A breach in this seal could compromise the sterility of the device, which is essential for any device intended for use inside the human body.
The affected lots are 14808819, NS14821223, and NS14851713, with expiration dates of 22 June 2027, 30 June 2027, and 21 July 2027 respectively. According to Cook, these specific lots have not been distributed beyond the company's distribution center.
The recalled product
- Product
- Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
- Manufacturer
- Cook Incorporated
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
- ModerateCook Inc. Recalls Movable Core Wire Guide Due to Labeling Error
FDA (Devices) · 2018-03-21
- HighCook Inc. Recalls Fixed Core Straight Safety Wire Guide
FDA (Devices) · 2020-02-12
- HighCook Inc. Recalls Wire Guide Due to Incorrect Loading Risk
FDA (Devices) · 2020-02-12
- SevereCook Inc. Recalls Fixed Core Wire Guides Due to Manufacturing Defects
FDA (Devices) · 2020-11-11
- ModerateCook Inc. Recalls Fixed Core Wire Guide Due to Heparin Labeling Error
FDA (Devices) · 2018-03-21
- HighVascular Wire Guide Recalled for Potential Sterility Compromise
FDA (Devices) · 2022-09-21