Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.

Recall Insight

This FDA Devices action (record #Z-2168-2021) was formally reported on August 11, 2021, with the manufacturer initiating the action on June 14, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. ROi CPS LLC is listed as the recalling firm, operating out of Republic, MO. Federal records indicate 688 units units are affected.

The documented reason for this recall is: Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others." Distribution data in the federal record shows the product reached: Missouri. 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.