Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

Recall Insight

This FDA Devices action (record #Z-0902-2022) was formally reported on April 20, 2022, with the manufacturer initiating the action on March 15, 2022. It is classified under Moderate severity (Class II), with a current status of Completed. Cardinal Health 200, LLC is listed as the recalling firm, operating out of Waukegan, IL. Federal records indicate 486,578 pairs units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Product was distributed without being sterilized. Distribution data in the federal record shows the product reached: Product distributed throughout United States and Guam. 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.