Tytek Tension Pneumothorax Kit Recall: Updated Instructions for Safety

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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 TPAK10 Tension Pneumothorax Access Kits made before October 5, 2020. The recall is for updated safety instructions to help prevent needle decompression risks during medical procedures.

Why it’s dangerous

The kit is designed for medical use to remove air from the pleural cavity during tension pneumothorax. Updated instructions address needle decompression risks but do not indicate a current hazard.

Who’s affected

Healthcare professionals using this kit for pneumothorax treatment may be affected. Patients using the kit under medical supervision are not at risk.

How to tell if you have this one

Check for model number TM-310 and unique device identifier (UDI) 00855204008020. Kits produced before October 5, 2020 are affected.

Brand
Tytek
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the model number and UDI to confirm if your kit is affected.

✎ GovInfoNow

Questions people ask

Is this kit dangerous to use?

No, the recall is for updated safety instructions, not an immediate hazard.

Do I need to stop using this kit?

No, the recall does not require stopping use; it's for improved instructions.

What should I do if I have this kit?

Check the model number and UDI to confirm if it's affected; no action is needed if it's not.

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-2611-2023 — Tytek Tytek

Hello,

I own a Tytek that is covered by recall Z-2611-2023 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-2611-2023 (October 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2611-2023 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 Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to

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