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.

Recall Insight

This FDA Devices action (record #Z-1711-2022) was formally reported on September 21, 2022, with the manufacturer initiating the action on July 19, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Cook Incorporated is listed as the recalling firm, operating out of Bloomington, IN. Federal records indicate 85 units units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.