TPAK TM-303Recalls & reported problems
TyTek Medical Inc. · Tension Pneumothorax Decompression Needle: 14 gauge x 3.25" · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Oct 5, 2020Terminated
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Z-2610-2023 · Root cause: Device Design · Recall details · FDA record ↗
Other Needle, Aspiration And Injection, Disposable devices
- N/A 305211Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE425 reports
- N/A 305180Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE300 reports
- N/A 305200Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE99 reports
- PneumoDart TM-317TyTek Medical Inc. · Needle, Aspiration And Injection, Disposable1 recall1 report
- N/A 305181Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE32 reports
- SOL-M™ Blunt Fill Needle with 5 Micron Filter 110022Sol-Millennium Medical, Inc. · Needle, Aspiration And Injection, Disposable17 reports
- CONFIDENCE SPINAL CEMENT SYSTEM 283903611Medos International Sàrl · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE17 reports
- CONFIDENCE SPINAL CEMENT SYSTEM 283903411Medos International Sàrl · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE15 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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