CriticalClass ITerminated

FDA Devices recall · Reported August 31, 2016

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; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metal

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on August 31, 2016. Severity: Critical. Recall number: Z-2537-2016.

Q: Where was the recalled product distributed?

Distribution: Worldwide distribution. US (nationwide), Australia, Austria, Belgium, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Jordan, Korea, Spain, South Africa, Taiwan, Turkey, and United Kingdom.

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-2537-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Potential coating contamination with glass particles.

Recall #: Z-2537-2016
Affected scope: 8,750 devices were distributed in commerce
Initiated: June 24, 2016

Compiled from official public sources by the editorial team. · Updated July 2026

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Cook Inc. recalled Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489;… - a critical-severity action.

Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489;… was recalled by Cook Inc. in August 31, 2016. Reason: Potential coating contamination with glass particles.. Check the official notice for the remedy. Verify recall #Z-2537-2016 with the FDA Devices before acting.

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The recall

Cook Inc. issued this critical-severity FDA Devices recall-Potential coating contamination with glass particles..

Critical
severity level: 9K units
affected scope: Class I
classification: August 31, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2537-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2537-2016) was formally reported on August 31, 2016, with the manufacturer initiating the action on June 24, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. Cook Inc. is listed as the recalling firm, operating out of Bloomington, IN. Federal records list the affected scope as 8,750 devices were distributed in commerce.

The documented reason for this recall is: Potential coating contamination with glass particles. Distribution data in the federal record shows the product reached: Worldwide distribution. US (nationwide), Australia, Austria, Belgium, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Jordan, Korea, Spain, South Africa, Taiwan, Turkey, and United Kingdom. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Critical

Affected scope

8,750 devices were distributed in commerce

Related Recalls

3 from same agency

Product description

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; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.

Reason for recall

Potential coating contamination with glass particles.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Critical (Class I)
Status	Terminated
Recall number	Z-2537-2016
Date reported	August 31, 2016
Date initiated	June 24, 2016
Recalling firm	Cook Inc.
Firm location	Bloomington, IN
Affected scope	8,750 devices were distributed in commerce
Distribution	Worldwide distribution. US (nationwide), Australia, Austria, Belgium, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Jordan, Korea, Spain, South Africa, Taiwan, Turkey, and United Kingdom

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

8,750 devices were distributed in commerce units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2537-2016) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Potential coating contamination with glass particles.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 31, 2016. Severity: Critical. Recall number: Z-2537-2016.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution. US (nationwide), Australia, Austria, Belgium, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Jordan, Korea, Spain, South Africa, Taiwan, Turkey, and United Kingdom.

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-2537-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 31, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.