Agency classClass IIOur severity:High FDA (Devices)·Z-1711-2022·Announced 2022-09-21

Vascular Wire Guide Recalled for Potential Sterility Compromise

Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging testing that may compromise device sterility. The affected lot numbers are 14095646 and 14174879.

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 device with potential sterility compromise due to failed packaging testing. No illnesses or injuries have been reported; the hazard is theoretical. This rating reflects the high-risk nature of a compromised sterile medical device used in vascular procedures, but without confirmed adverse events.

Plain-English summary

Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide (reference part number HPWA-18-150) used for vascular catheter positioning and exchange in diagnostic and interventional procedures.

The devices did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing. Because of this failure, the sterility of the affected devices may be compromised.

Approximately 85 units were distributed with lot numbers 14095646 and 14174879 to facilities nationwide and in multiple countries internationally.

Consumers and healthcare providers who possess these devices should contact Cook Incorporated for instructions on the recall.

The recalled product

Product: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Manufacturer: Cook Incorporated
Category: Medical Device — Vascular Catheter Guide
Hazard: sterility-compromise
infection-risk
Affected units: 85

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 (2)

UDI-DI: (01)00827002561618- Lot Numbers: 14095646
14174879

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