Agency classClass IIOur severity:High FDA (Devices)·Z-1715-2022·Announced 2022-09-21

Vascular catheter wire guide recalled for sterility testing failure

Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides due to packaging testing failures that may compromise device sterility. The recall affects 865 units 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 Class II medical device recall involves compromised sterility from failed packaging testing. Although no illnesses or injuries have been reported, compromised sterility in a vascular catheter device qualifies as a risk-of-harm product where injury has not yet occurred, per the severity rubric.

Plain-English summary

Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides (Reference Part Number HPWAS-35-150, Order Number G56176). These devices are used for vascular catheter positioning and exchange in diagnostic and interventional procedures.

The devices failed to meet acceptance criteria for packaging testing, including 3-year age acceleration testing. The company determined that sterility of the device may be compromised as a result.

The recall involves 865 units with the following lot numbers: 14112845, NS14062106, NS14080814, NS14089120, NS14118843, NS14139358, NS14142006, NS14144747, NS14148490, NS14149799, NS14153797, NS14172915. These devices were distributed nationwide and to multiple countries internationally.

The recalled product

Product: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Manufacturer: Cook Incorporated
Category: Medical Device — Vascular Catheter Guide
Hazard: sterility-compromise
Affected units: 865

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 (12)

UDI-DI: (01)00827002561762- Lot Numbers: 14112845
NS14062106
NS14080814
NS14089120
NS14118843
NS14139358
NS14142006
NS14144747
NS14148490
NS14149799
NS14153797
NS14172915

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