Roadrunner PC Wire Guide Recalled for Packaging Breach and Sterility Compromise
Cook Incorporated recalls Roadrunner PC Wire Guide devices due to packaging seal breaches that may compromise sterility. Devices were distributed nationwide 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 is an FDA Class II recall involving potential sterility compromise of medical devices used in surgical procedures. While no illnesses or injuries have been reported, sterility compromise of medical devices represents a high-risk-of-harm situation where injury has not yet been reported, meeting Score 3 criteria.
Plain-English summary
Cook Incorporated is recalling Roadrunner PC Wire Guide devices (Reference Part Numbers RPC-35-145 and RPC-35-80) due to a packaging integrity issue identified in affected device lots.
The manufacturer identified that affected devices may have a complete breach of the chevron seal of the packaging. This breach may compromise the sterility of the devices, which is critical for safe use in medical applications.
A total of 363 units were distributed in the United States and 244 units were distributed internationally. The devices were distributed nationwide domestically and worldwide internationally.
Healthcare providers should contact Cook Incorporated for guidance on affected lot numbers, expiration dates, return procedures, and replacement options.
The recalled product
- Product
- Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
- 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
- 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
- HighRoadrunner UniGlide Hydrophilic Wire Guide Sterility Compromise Recall
FDA (Devices) · 2022-09-21