Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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) 22ga SPiN Flex Nee... | 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 | 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 9800 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 | OEC Elite 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 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 | 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 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 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 GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA | 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 TMX428CP 220V, MODEL NUMBER 317-07929 | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate... | Class II | Full Vision Inc |
| May 12, 2023 | Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; I... | A mechanical lock used to connect and release a locking liner into a prosthetic socket have an at... | Class II | Ossur H / F |
| 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 |
| May 12, 2023 | Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000 | The scissors were manufactured without a tip protector resulting in the scissors breaking through... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| 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 10, 2023 | PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Devic... | When multiple processes are running on the watch's Central Processing Unit (CPU), the application... | Class II | Permobil |
| May 10, 2023 | PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Devic... | When multiple processes are running on the watch's Central Processing Unit (CPU), the application... | Class II | Permobil |
| May 10, 2023 | LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 | Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-S... | Class II | Fresenius Kabi USA, LLC |
| May 9, 2023 | QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and ... | If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY00... | Class II | Qiagen GmbH |
| May 9, 2023 | vRad PACS with Mammography | The error resulted in intermittent failure of current (primary) radiology study images not displa... | Class II | Virtual Radiologic Corp. |
| May 8, 2023 | Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12,... | Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer c... | Class II | Galt Medical Corporation |
| May 8, 2023 | BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IV... | Due to manufacturing issue, panels may result in false negative results. | Class II | BioFire Diagnostics, LLC |
| May 8, 2023 | Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 | Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer c... | Class II | Galt Medical Corporation |
| May 8, 2023 | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 | Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainb... | Class II | Remote Diagnostic Technologies Ltd. |
| May 8, 2023 | FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems... | Due to manufacturing issue, panels may result in false negative results. | Class II | BioFire Diagnostics, LLC |
| May 8, 2023 | VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VI... | Potential to cause biased results in the upper end of the reportable range for the quantitative m... | Class II | Ortho-Clinical Diagnostics |
| May 5, 2023 | bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ven... | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bell... | Class II | Vyaire Medical |
| May 5, 2023 | bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Vent... | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bell... | Class II | Vyaire Medical |
| May 5, 2023 | Elekta Medical Linear Accelerator (ELMA) included in the below platforms: ... | A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC... | Class II | Elekta, 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.