Tytek Medical Recalls PneumoDart Devices Due to Occluded Needle Defect
Tytek Medical Inc is recalling 3,565 PneumoDart devices because a defect involving an occluded needle was discovered during a training exercise.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could prevent it from functioning as intended in a life-threatening emergency (tension pneumothorax). This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Tytek Medical Inc is recalling 3,565 units of the PneumoDart, 14 ga x 3.25in. (REF TM-317). This compact, sterile device is intended for introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.
The recall was initiated after a defect involving an occluded needle was discovered during a training exercise. The affected units are identified by NSN 6515-01-655-9514, Lot number 190524J69, and have an expiration date of May 24, 2026.
The devices were distributed nationwide in the United States, as well as in Europe, Australia, and Hong Kong. Healthcare facilities and users should stop using the affected devices and contact Tytek Medical Inc for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Tytek Medical Inc
- Affected units
- 3,565
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24
- 2026
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Tytek Medical Inc
See all →- ModerateTyTek Tension Pneumothorax Access Kit Instructions Updated for Needle Decompression Safety
FDA (Devices) · 2023-09-27
- HighTyTek PneumoDart Decompression Device: Updated Instructions for Needle Placement
FDA (Devices) · 2023-09-27
- HighTyTek Tension Pneumothorax Access Kit Recalled for Inadequate Placement Instructions
FDA (Devices) · 2023-09-27
Same hazard · device defect
See all →- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22