Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE

Recall Insight

This FDA Devices action (record #Z-0847-2024) was formally reported on February 14, 2024, with the manufacturer initiating the action on December 28, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Cardinal Health 200, LLC is listed as the recalling firm, operating out of Waukegan, IL. Federal records indicate 20186 units units are affected.

The documented reason for this recall is: The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends t… Distribution data in the federal record shows the product reached: Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.. 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 2 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.