Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)

Recall Insight

This FDA Devices action (record #Z-1825-2022) was formally reported on October 5, 2022, with the manufacturer initiating the action on August 16, 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 488 US, 5 OUS units are affected.

The documented reason for this recall is: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. Distribution data in the federal record shows the product reached: Domestic distribution nationwide. Foreign distribution worldwide.. 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.