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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 4 FDA device recalls.

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DateProductReasonClassFirm
Oct 5, 2020 TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended f... Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompressio... Class II Tytek Medical Inc
Oct 5, 2020 TyTek PneumoDart- Intended for introduction into the body to facilitate remov... Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompressio... Class II Tytek Medical Inc
Oct 5, 2020 TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for i... Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompressio... Class II Tytek Medical Inc
Nov 15, 2019 PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intende... A defect involving an occluded needle was discovered during a training exercise. Class I Tytek Medical Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.