regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

Recall Insight

This FDA Devices action (record #Z-1047-2025) was formally reported on February 12, 2025, with the manufacturer initiating the action on December 26, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. ROi CPS LLC is listed as the recalling firm, operating out of Republic, MO. Federal records indicate 414 kits units are affected.

The documented reason for this recall is: There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of… Distribution data in the federal record shows the product reached: Distribution was made to MO. There was no government/military/foreign distribution.. 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 1 year 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.