Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.

Recall Insight

This FDA Devices action (record #Z-0003-2022) was formally reported on October 13, 2021, with the manufacturer initiating the action on September 13, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Perfusion Systems is listed as the recalling firm, operating out of Brooklyn Park, MN. Federal records indicate 168 kits units are affected.

The documented reason for this recall is: There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.. 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 5 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.