Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
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Contact the company
📍Recalling firmTytek Medical Inc8904 Beckett Rd · West Chester, OH 45069-7054
“Tytek Tension Pneumothorax Kit Recall: Updated Safety Instructions.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64120-tytek-tension-pneumothorax-kit-recall-updated-safety-instructions. Based on FDA recall #Z-2610-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2610-2023%22&limit=1).
The FDA announced on Oct. 5, 2020, that Tytek Medical Inc is recalling its TyTek Tension Pneumothorax Access Kit due to an updated Instructions for Use that fails to adequately identify needle decompression risks and improve placement site artwork. The agency classified the recall as Class II.
The recall addresses an updated Instructions for Use that does not sufficiently identify risks associated with needle decompression and lacks improved artwork showing the placement site location.
Context
GovInfoNow's records show Tytek Medical Inc has one other recall on record since Nov. 15, 2019, involving a PneumoDart product with an occluded needle risk. Other recent recalls of similar products include Medline Tonsil Pack Catheter Kits (May 4, 2026), Medline ENT Kits (Feb. 25, 2026), and Medline Hysteroscopy and Sling Packs (Feb. 25, 2026).
How to tell if you have this one
Check for model number TM-303 on the kit. Products were made before October 5, 2020 and sold under the brand Tytek Medical.
Brand
Tytek Medical
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK
Recall number
Product, codes & lots
Quantity
Z-2610-2023
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; UDI: 00855204008006 All lots produced prior to Oct 5, 2020
439146 units
Z-2611-2023
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; UDI: 00855204008020 All lots produced prior to Oct 5, 2020
4400 units
Z-2612-2023
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; UDI: 00855204008167 All lots produced prior to Oct 5, 2020
22,026 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for model number TM-303 and production date before October 5, 2020 on the kit.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Ohio, South Carolina, Virginia.
Recall timeline
FDA terminated this recall 5.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2610-2023 (October 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2610-2023 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.