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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Sep 26, 2019 TLC-2000 Therapeutic Medical Laser System 660 nm laser diodes may be below rated power output. Class III Theralase Inc.
Sep 26, 2019 TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Use... Device was shipped without a Unique Device Identification (UDI) label and a separate label identi... Class III Theralase Inc.
Sep 26, 2019 TLC-2000 Therapeutic Medical Laser System 905 nm laser diodes may be below rated power output. Class III Theralase Inc.
Sep 26, 2019 TLC-2000 Therapeutic Medical Laser System Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-... Class III Theralase Inc.
Sep 26, 2019 TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and I... Class III Theralase Inc.
Sep 26, 2019 TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the ... Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple ... Class III Theralase Inc.
Sep 26, 2019 TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of k... Device was shipped without a Unique Device Identification (UDI) label. Class III Theralase 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.