PneumoDart — Class I medical device recall Z-0930-2020
Terminated recall by Tytek Medical Inc, reported 2020-02-19, distributed nationwide. A defect involving an occluded needle was discovered during a training exercise.
| Recall number | Z-0930-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tytek Medical Inc, Blue Ash, OH, United States |
| Recall initiated | 2019-11-15 |
| Classified | 2020-02-12 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2020-10-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, HK |
| Quantity | 3,565 units |
| Lot numbers | 190524J69 |
| Model numbers | TM-317A |
| Expiration dates | 2026-05-24 |
Product
PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.
Reason for recall
A defect involving an occluded needle was discovered during a training exercise.
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-0930-2020. 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.