Unrated Medical device recall · FDA · Published November 15, 2019

Tytek Medical PneumoDart Recall: Occluded Needle Risk

Tytek Medical recalls PneumoDart 14-gauge needles due to a defect that may cause occlusion during use. Affected units were sold with specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0930-2020Medical device Tytek Medical ›

Recall notice

A defect involving an occluded needle was discovered during a training exercise.

Take action

Contact the company

Recalling firmTytek Medical Inc4700 Ashwood Dr Ste 445 · Blue Ash, OH 45241-2684

✎ GovInfoNow plain-language explainer

Tytek Medical is recalling PneumoDart 14-gauge needles because a defect could cause the needle to become occluded during use. This risk may affect medical procedures involving air removal from the pleural cavity. Read more at govinfonow.com/recall/66514-tytek-medical-pneumodart-recall-occluded-needle-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66514-tytek-medical-pneumodart-recall-occluded-needle-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0930-2020

Cite this page

“Tytek Medical PneumoDart Recall: Occluded Needle Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66514-tytek-medical-pneumodart-recall-occluded-needle-risk. Based on FDA recall #Z-0930-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0930-2020%22&limit=1).

Tytek Medical Inc recalled PneumoDart, 14 ga x 3.25in., REF TM-317 A devices due to a defect involving an occluded needle, the FDA said on Nov. 15, 2019.

How to tell if you have it

Brand: Tytek Medical
Product: PneumoDart, 14 ga x 3.25in., REF TM-317 A
NSN: 6515-01-655-9514
Lot number: 190524J69
Expiration Date: May 24, 2026
Quantity: 3,565 units

The hazard

A defect involving an occluded needle was discovered during a training exercise.

Context

GovInfoNow's records show Tytek Medical Inc has 1 other recall on record since 2020-10-05. On 2020-10-05, the company issued an updated instructions for safety recall regarding risks associated with needle decompression. Other recent recalls of similar products include Medtronic GUNDRY Cannula Recall (2026-04-21) and Medline Airway Exam Kit Recall (2026-02-16).

How to tell if you have this one

Check for the product name 'PneumoDart', 14-gauge size, and lot number 190524J69. The expiration date is May 24, 2026.

Brand
Tytek Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the lot number and expiration date on the device packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “US (nationwide), and countries of: Europe, Australia and Hong Kong.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Nov 15, 2019Firm started the recall
Feb 12, 2020FDA classified it Class I
Feb 19, 2020Published in FDA’s Enforcement Report
Oct 1, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/66514-tytek-medical-pneumodart-recall-occluded-needle-risk">Tytek Medical PneumoDart Recall: Occluded Needle Risk (GovInfoNow)</a>

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-0930-2020 (November 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0930-2020 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.