Agency classClass IIOur severity:High FDA (Devices)·Z-1708-2022·Announced 2022-09-21

Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Testing Failure

Cook Incorporated is recalling 1,450 units of Roadrunner PC Hydrophilic Wire Guide devices due to failed sterility packaging testing. The devices may not meet sterility requirements for safe use in vascular procedures.

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 recall of a high-risk sterile medical device with potential sterility compromise. No illnesses or injuries have been reported, and the hazard remains theoretical based on failed packaging testing. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.

Plain-English summary

Cook Incorporated is recalling 1,450 units of the Roadrunner PC Hydrophilic Wire Guide (Reference Part Number RLPC-35-180, Order Number G07516). This medical device is used for vascular catheter positioning and exchange in diagnostic and interventional procedures.

The devices did not meet acceptance criteria for packaging testing, including 3-year age acceleration testing. As a result, the sterility of the devices may be compromised, which could pose a risk to patients undergoing vascular procedures.

The affected devices were distributed nationwide and internationally. Affected lot numbers include 14103953, 14103956, 14143728, 14145412, 14145419, 14153927, 14156907, 14156908, 14156914, and 14160996.

Healthcare providers and patients should contact Cook Incorporated for instructions regarding device return or replacement.

The recalled product

Product: Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Manufacturer: Cook Incorporated
Category: Medical Device — Vascular Guide Wire
Hazard: sterility-compromise
infection-risk
Affected units: 1,450

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 (10)

UDI-DI: (01)00827002075160- Lot Numbers: 14103953
14103956
14143728
14145412
14145419
14153927
14156907
14156908
14156914
14160996

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 13 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 13 products in this recall →

Same manufacturer · Cook Incorporated

See all →

Moderate
Cook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
Critical
Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
Severe
Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
Critical
Cook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
High
Cook Medical CTO-18 wire guides labeled with overstated expiration dates
FDA (Devices) · 2026-04-15

Same hazard · sterility compromise