Tytek PneumoDart Recall: Needle Decompression Risk

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Recalling firmTytek Medical Inc8904 Beckett Rd · West Chester, OH 45069-7054

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Tytek Medical is recalling PneumoDart devices made before October 5, 2020. These devices are used for air removal in pleural cavities during tension pneumothorax treatment. The recall addresses updated instructions to clarify risks from needle decompression procedures.

Why it’s dangerous

The device is designed to remove air from the pleural cavity during tension pneumothorax treatment. Updated instructions clarify risks associated with needle decompression procedures to ensure safe use.

Who’s affected

Patients with tension pneumothorax who use the PneumoDart device for air removal are affected. Medical professionals using the device before October 5, 2020 are most at risk.

How to tell if you have this one

Check for model number TM-317 and unique device identifier 00855204008167. Devices were produced before October 5, 2020.

Brand
Tytek
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Look for model number TM-317 and unique device identifier 00855204008167 on the device.

✎ GovInfoNow

Questions people ask

Why is this device being recalled?

The recall updates instructions to clarify risks associated with needle decompression procedures for safer use.

What is the model number for this device?

The model number is TM-317.

When were these devices produced?

Devices were produced before October 5, 2020.

Take action

Contact Tytek

We’ve drafted a message you can send Tytek to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2612-2023 — Tytek Tytek

Hello,

I own a Tytek that is covered by recall Z-2612-2023 from Tytek.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2612-2023 (October 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2612-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Tytek Medical Inc recalls TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in

Lower-risk recall