FDA Recalls Cook Roadrunner PC Wire Guides for Packaging Sterility Breach
Cook Incorporated is recalling Roadrunner PC Wire Guide devices due to a breach in packaging's chevron seal that may compromise sterility. Affected devices should not be used.
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 guidewire recall with sterility-compromising packaging defect poses significant infection risk in invasive medical procedures. No injuries or illnesses reported, but per rubric criteria for risk-of-harm products without reported injury, severity is High (3).
Plain-English summary
Cook Incorporated is recalling specific lots of the Roadrunner PC Wire Guide (Nimble), a guidewire medical device used in interventional procedures. The recall affects 277 units distributed in the United States and 138 units distributed internationally.
The devices are being recalled because the packaging's chevron seal may be completely breached in affected units, which compromises the sterility of the device. Sterile packaging is critical for medical devices used in invasive procedures to prevent infection.
Affected lot numbers are: 14831437, 14831438, 14835040, 14840287, 14840288, and 14840309. Healthcare providers and patients who have these devices should not use them. Contact Cook Incorporated or your healthcare provider for guidance on replacement or return of affected devices.
The recalled product
- Product
- Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
- 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
- HighRoadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Compromise
FDA (Devices) · 2022-09-21
- HighRoadrunner PC Wire Guide Recalled for Sterility Testing Failure
FDA (Devices) · 2022-09-21
- HighRoadrunner PC Hydrophilic Wire Guide Recalled Due to Packaging Integrity Failure
FDA (Devices) · 2022-09-21
- HighRoadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Testing Failure
FDA (Devices) · 2022-09-21
- HighRoadrunner UniGlide Vascular Wire Guide Recalled for Sterility Compromise
FDA (Devices) · 2022-09-21
- HighVascular Wire Guide Recalled Due to Sterility Concerns From Packaging Failure
FDA (Devices) · 2022-09-21