Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
PneumoDart Recalled by Tytek Medical Inc Due to A defect involving an occluded needle was discovered...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tytek Medical Inc directly.
Affected Products
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.
Quantity: 3,565 units
Why Was This Recalled?
A defect involving an occluded needle was discovered during a training exercise.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tytek Medical Inc
Tytek Medical Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report