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# Tytek Medical Recalls PneumoDart
- URL: https://www.fdaweb.com/tytek-medical-recalls-pneumodart/
- Published: 2020-02-13T12:00:00.000Z
- Updated: 2026-09-14T16:02:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146091

FDA has classified as Class 1 a Tytek Medical recall of its PneumoDart, a compact, sterile, device that the agency says is “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.” A [recall notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=177975&ref=fdaweb.com) says the recall is attributed to a defect involving an occluded needle that was discovered during a training exercise.