TyTek PneumoDart- Intended for introduction into the body to… — Class II medical device recall Z-2612-2023
Terminated recall by Tytek Medical Inc, reported 2023-09-27, distributed in OH, SC, VA. Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) imp
| Recall number | Z-2612-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tytek Medical Inc, West Chester, OH, United States |
| Recall initiated | 2020-10-05 |
| Classified | 2023-09-19 |
| Reported by FDA | 2023-09-27 |
| Terminated | 2026-03-13 |
| Distributed | OH, SC, VA |
| Countries outside the US | AE, AU, CN, DE, DK, ES, FI, GB, HK, IL, NL, TR |
| Quantity | 22,026 units |
| UPC / GTIN / UDI-DI | 00855204008167 |
| Model numbers | TM-317 |
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
Reason for recall
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2612-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.