Lower risk Medical device recall · FDA · Published July 19, 2022

Cook Roadrunner UniGlide Hydrophilic Wire Guide Recall: Sterility Risk

Cook recalls Roadrunner UniGlide Hydrophilic Wire Guide (RPN HPWAS-35-150) due to potential sterility compromise from inadequate packaging testing. Affected units include specific lot numbers for vascular catheter procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1715-2022Medical device Cook ›

Lower-risk recall

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Take action

Contact the company

Recalling firmCook Incorporated750 N Daniels Way · Bloomington, IN 47404-9120

✎ GovInfoNow plain-language explainer

Cook is recalling its Roadrunner UniGlide Hydrophilic Wire Guide devices because the packaging may not have passed long-term testing, risking contamination. This could lead to infections if the device is used in medical procedures without proper sterility. Read more at govinfonow.com/recall/60339-cook-roadrunner-uniglide-hydrophilic-wire-guide-recall-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/60339-cook-roadrunner-uniglide-hydrophilic-wire-guide-recall-sterility-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1715-2022

Cite this page

“Cook Roadrunner UniGlide Hydrophilic Wire Guide Recall: Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60339-cook-roadrunner-uniglide-hydrophilic-wire-guide-recall-sterility-risk. Based on FDA recall #Z-1715-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1715-2022%22&limit=1).

The FDA announced on July 19, 2022, that Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide because packaging testing failures may compromise device sterility. The agency issued recall number Z-1715-2022 for the Class II medical device.

How to tell if you have it

Brand: Cook
Product: Roadrunner UniGlide Hydrophilic Wire Guide
RPN: HPWAS-35-150
GPN: G56176
UPC: 00827002561762
Lot Numbers: 14112845, NS14062106, NS14080814, NS14089120, NS14118843, NS14139358, NS14142006, NS14144747, NS14148490, NS14149799, NS14153797, NS14172915
Units: 865

The hazard

The product did not meet acceptance criteria for packaging testing, including three-year age acceleration testing. Consequently, the sterility of the device may be compromised.

Context

GovInfoNow's records show Cook Incorporated has 15 other recalls on record since May 5, 2022. Recent Cook recalls include the April 2, 2026 Centimeter Sizing Catheters Recall regarding marker band cracking and the March 5, 2026 NCompass Nitinol Stone Extractor Recall for expiration dates exceeding shelf life. Other recent recalls of similar products include the April 10, 2026 Stryker Daig Livewire Steerable Catheter Recalls for incomplete sterile seals and the January 7, 2026 Medline Convenience Kits Recall for sterility risk from calibration issues.

How to tell if you have this one

Check for reference part number HPWAS-35-150 and order number G56176. Affected units include specific lot numbers listed in the recall notice.

Brand
Cook
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For
Category
Medical device

FDA recall event · 13 products

All 13 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

Recall number	Product, codes & lots	Quantity
Z-1706-2022	Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.; UDI-DI: (01)00827002079373- Lot Numbers: 14145420, 14145424, 14156909, 14156912, 14156916, 14164348, 14173577	496 units
Z-1707-2022	Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.; UDI-DI: (01)00827002096080- Lot Numbers: 14071906, 14091204, 14134663, 14134667, 14134669, 14134670, 14134673, 14134676, 14143872, 14143873, 14160997, 14184102, NS14143735, NS14152903	2407 units
Z-1708-2022	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.; UDI-DI: (01)00827002075160- Lot Numbers: 14103953, 14103956, 14143728, 14145412, 14145419, 14153927, 14156907, 14156908, 14156914, 14160996	1450 units
Z-1709-2022	Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.; UDI-DI: (01)00827002075184 Lot Numbers: 14063361, 14087089, 14087092, 14117033, 14120926, 14120928, 14151216, 14151218, 14153159, 14158614, 14159695, 14159696	1997 units
Z-1710-2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.; UDI-DI: (01)00827002561496- Lot Numbers: 14070921, 14108915, 14108916, 14129152, 14141997, 14170230	585 units
Z-1711-2022	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.; UDI-DI: (01)00827002561618- Lot Numbers: 14095646, 14174879	85 units
Z-1712-2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.; UDI-DI: (01)00827002561625- Lot Numbers: 14070920, 14174878	35 units
Z-1713-2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.; UDI-DI: (01)00827002561731- Lot Numbers: 14070910, 14070913, 14070914, 14070915, 14070916, 14070917, 14080810, 14104898, 14104899, 14104902, 14106628, 14106629, 14120473, 14120474, 14120475, 14122089, 14122091, 14122093, 14122095, 14122322, 14129155, 14129156, 14129157, 14129158, 14129161, 14129162, 14129163, 14131012, 14131013, 14131014, 14134680, 14134681, 14134683, 14134684, 14139356, 14142001, 14142004, 14142005, 14142007, 14147337, 14147338, 14147339, 14148371, 14160531, 14160533, 14160534, NS14095649, NS14122100, NS14122327, NS14129168, NS14131010, NS14131011, NS14131015, NS14133505, NS14142008, NS14147334, NS14147335, NS14147336, NS14147336X, NS14153793, NS14176970	5400 units
Z-1714-2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.; UDI-DI: (01)00827002561724- Lot Numbers: 14156569	75 units
Z-1715-2022	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.; UDI-DI: (01)00827002561762- Lot Numbers: 14112845, NS14062106, NS14080814, NS14089120, NS14118843, NS14139358, NS14142006, NS14144747, NS14148490, NS14149799, NS14153797, NS14172915	865 units
Z-1716-2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.; UDI-DI: (01)00827002561755- Lot Numbers: 14174876, 14174880, NS14104906, NS14173970, NS14173971	189 units
Z-1717-2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.; UDI-DI: (01)00827002561526- Lot Numbers: 14118842	30 units
Z-1718-2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.; UDI-DI: (01)00827002561519- Lot Numbers: 14156572	15 units

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for lot numbers on the device packaging: 14112845, NS14062106, NS14080814, NS14089120, NS14118843, NS14139358, NS14142006, NS14144747, NS14148490, NS14149799, NS14153797, NS14172915.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Jul 19, 2022Firm started the recall
Sep 9, 2022FDA classified it Class II
Sep 21, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/60339-cook-roadrunner-uniglide-hydrophilic-wire-guide-recall-sterility-risk">Cook Roadrunner UniGlide Hydrophilic Wire Guide Recall: Sterility Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1715-2022 (July 19, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1715-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.