Cook Roadrunner PC Guidewire Recalled for Compromised Packaging Seal
Cook Incorporated recalls Roadrunner PC Wire Guide devices due to a potential packaging seal breach that may compromise sterility. The recall affects 115 units distributed domestically 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 a Class II medical device recall involving a potential compromise of device sterility from a packaging seal defect. No illnesses or injuries have been reported. This constitutes a risk-of-harm product without reported injury, meeting the criterion for High (3) severity.
Plain-English summary
Cook Incorporated has recalled Roadrunner PC Wire Guide (The Firm LT) devices, model RLPC-35-145 (UDI-DI: 00827002068667). The recall affects 115 units.
Cook Medical identified that devices from the affected lots may have a complete breach of the chevron seal of the packaging, which may compromise the sterility of the devices. The affected lots are 14828631, 14828643, and 14828644, all with an expiration date of June 7, 2025.
The devices were distributed domestically throughout the United States and internationally worldwide. Healthcare providers and patients who may have received these devices should contact Cook Incorporated for identification and handling instructions regarding the affected units.
The recalled product
- Product
- Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
- Manufacturer
- Cook Incorporated
- Affected units
- 115
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
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 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 UniGlide Vascular Wire Guide Recalled for Sterility Compromise
FDA (Devices) · 2022-09-21
- HighVascular Catheter Wire Guide Recalled for Possible Sterility Compromise
FDA (Devices) · 2022-09-21