Cook Inc. Recalls Roadrunner Uniglide Hydrophilic Wire Guides Due to Glass Contamination
Cook Inc. is recalling Roadrunner Uniglide Hydrophilic Wire Guides because they may be contaminated with glass particles. The recall covers 8,750 devices distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential coating contamination with glass particles."
Plain-English summary
Cook Inc. is recalling the Roadrunner Uniglide Hydrophilic Wire Guide, a medical device used with vascular catheters. The recall is being conducted because the devices may be contaminated with glass particles. The affected products are constructed from a steerable, metallic core with a polymer coating and a hydrophilic coating applied over a radiopaque polymer jacket.
A total of 8,750 devices were distributed in commerce. The distribution was worldwide, including the United States (nationwide), Australia, Austria, Belgium, Canada, China, the Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Jordan, Korea, Spain, South Africa, Taiwan, Turkey, and the United Kingdom. The recall includes specific catalog numbers and GPNs, as well as a list of specific lot numbers.
Healthcare providers and consumers should stop using the affected devices and contact Cook Inc. for further instructions or a replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172…
- Manufacturer
- Cook Inc.
- Affected units
- 8,750
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 (20)
- Roadrunner Uniglide Hydrophilic Wire Guide
- Catalog Numbers and GPN: HPWA-18-260
- G30489
- HPWA-18-320
- G30490
- HPWA-25-260
- G30491
- HPWA-35-260
- G30492
- HPWAS-35-260
- G30506
- HPW-35-150
- G56149
- HPW-35-180
- G56150
- HPWS-35-150
- G56152
- HPWS-35-180
- G56153
- HPWA-35-80
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Cook Inc.
See all →- HighSkinny Needle with Chiba Tip recalled for debris contamination
FDA (Devices) · 2021-12-29
- HighCook Flexor Check-Flo Introducer recalled for size mislabeling
FDA (Devices) · 2021-12-22
- ModerateFlexor Check-Flo Introducer Recalled for Mislabeled Caliber Size
FDA (Devices) · 2021-12-22
- HighTransseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
- HighTransseptal Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
Same hazard · foreign object contamination
See all →- LowLevothyroxine Sodium tablets recalled for foreign substance contamination
FDA (Drugs) · 2025-06-18
- HighCelecoxib Capsules Recalled for Foreign Tablet Contamination
FDA (Drugs) · 2025-06-18
- HighSalsa Cilantro recalled for potential foreign object contamination
FDA (Food) · 2025-06-11
- SevereTestosterone Pellet 200 mg Recalled Due to Glass Particles
FDA (Drugs) · 2025-05-14
- HighEllington Farms Lemonade Drink Mix recalled for metal fragment contamination
FDA (Food) · 2024-12-11
Similar recalls
- HighVascular Wire Guide Recalled Due to Sterility Concerns From Packaging 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
- HighVascular catheter wire guide recalled for sterility testing failure
FDA (Devices) · 2022-09-21
- HighVascular Wire Guide Recalled for Potential Sterility Compromise
FDA (Devices) · 2022-09-21
- HighRoadrunner UniGlide Hydrophilic Wire Guide Sterility Compromise Recall
FDA (Devices) · 2022-09-21