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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Jul 24, 2025 Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Softwa... The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... Class II THOR Photomedicine Ltd
Jul 24, 2025 Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Numbe... The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... Class II THOR Photomedicine Ltd
Jul 24, 2025 Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Sof... The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... Class II THOR Photomedicine Ltd
Jul 24, 2025 Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Numbe... The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... Class II THOR Photomedicine Ltd
Nov 20, 2023 NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) P... One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of in... Class II THOR Photomedicine Ltd
Sep 13, 2022 NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184. Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki... Class II Thor Photomedicine Ltd
Sep 13, 2022 G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177 Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki... Class II Thor Photomedicine Ltd
Sep 13, 2022 NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176 Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki... Class II Thor Photomedicine Ltd
Sep 13, 2022 NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183 Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki... Class II Thor Photomedicine Ltd

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.