The Recall Desk

Manufacturer

Tytek Medical Inc

4 recalls in our database name Tytek Medical Inc as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
1
Most recent
2023-09-27

Of the 4 recalls from Tytek Medical Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (25%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • HighFDA (Devices)·Z-2610-2023·2023-09-27

    TyTek Tension Pneumothorax Access Kit Recalled for Inadequate Placement Instructions

    Tytek Medical Inc is recalling the TyTek Tension Pneumothorax Access Kit (Model TM-303) because the instructions do not adequately identify the risks associated with needle decompression or clearly show proper placement site location.

    Product
    TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2612-2023·2023-09-27

    TyTek PneumoDart Decompression Device: Updated Instructions for Needle Placement

    Tytek Medical is updating instructions for the TyTek PneumoDart to better identify needle decompression risks and improve placement guidance. Approximately 22,026 units distributed before October 5, 2020 are affected.

    Product
    TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2611-2023·2023-09-27

    TyTek Tension Pneumothorax Access Kit Instructions Updated for Needle Decompression Safety

    Tytek Medical is updating instructions and visual guidance for its tension pneumothorax kit to clarify needle decompression risks and proper placement. The update affects 4,400 units distributed in the US and international locations.

    Product
    TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-310
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0930-2020·2020-02-19

    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.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide