Browse Device Recalls

39,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,969 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 39,969 FDA device recalls.

DateProductReasonClassFirm
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 OEC 9900 Systems with 9-inch Image Intensifier Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detach... Class II GE OEC Medical Systems, Inc
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histolog... Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... Class II Olympus Corporation of the Americas
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm O... Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... Class II Olympus Corporation of the Americas
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology... Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... Class II Olympus Corporation of the Americas
May 15, 2023 Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PAR... Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detach... Class II GE OEC Medical Systems, Inc
May 15, 2023 Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the fo... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 OEC Flexiview 8800 Systems with 9-inch Image Intensifier Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detach... Class II GE OEC Medical Systems, Inc
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD... Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... Class II Olympus Corporation of the Americas
May 15, 2023 Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.... Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... Class II Olympus Corporation of the Americas
May 15, 2023 Philips Respironics V60 Ventilator-Intended to mechanically control or assist... Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may po... Class II DRE Medical Group Inc
May 15, 2023 Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD,... Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... Class II Olympus Corporation of the Americas
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brus... Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... Class II Olympus Corporation of the Americas
May 12, 2023 TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928 Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate... Class II Full Vision Inc
May 12, 2023 TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927 Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate... Class II Full Vision Inc
May 12, 2023 TRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GE Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate... Class II Full Vision Inc
May 12, 2023 TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GE Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate... Class II Full Vision Inc
May 12, 2023 Driver Instrument, part of the Superion Indirect Decompression System, REF: 1... Pending update to indirect decompression system instructions for use informing users that excessi... Class II Boston Scientific Neuromodulation Corporation
May 12, 2023 TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926 Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate... Class II Full Vision 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.