PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.

Recall Insight

This FDA Devices action (record #Z-0930-2020) was formally reported on February 19, 2020, with the manufacturer initiating the action on November 15, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Tytek Medical Inc is listed as the recalling firm, operating out of Blue Ash, OH. Federal records indicate 3,565 units units are affected.

The documented reason for this recall is: A defect involving an occluded needle was discovered during a training exercise. Distribution data in the federal record shows the product reached: US (nationwide), and countries of: Europe, Australia and Hong Kong.. 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 6 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.