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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,969 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 2,969 FDA device recalls in PA.

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DateProductReasonClassFirm
Jul 31, 2019 SOMATOM go.Top; Models #11061648 Product Usage: This computed tomograph... The injector holder could potentially fall off together with the injector and the storage box. Class II Siemens Medical Solutions USA, Inc
Jul 31, 2019 SOMATOM go.Top; Models #11061640 Product Usage: This computed tomograph... The injector holder could potentially fall off together with the injector and the storage box. Class II Siemens Medical Solutions USA, Inc
Jul 30, 2019 Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with p... Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause... Class II Siemens Medical Solutions USA, Inc
Jul 25, 2019 syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomog... SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT ... Class II Siemens Medical Solutions USA, Inc
Jul 23, 2019 Mammomat Revelation with software version VC10 and Biopsy Option Intended ... An error can occur when performing a biopsy using the InSpect function. The acquisition workstati... Class II Siemens Medical Solutions USA, Inc
Jul 18, 2019 Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circ... Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm ... Class II Arrow International Inc
Jul 10, 2019 Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation... Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability Class II Siemens Medical Solutions USA, Inc
Jul 10, 2019 ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is... Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability Class II Siemens Medical Solutions USA, Inc
Jul 10, 2019 CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is... Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability Class II Siemens Medical Solutions USA, Inc
Jul 10, 2019 CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is t... Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability Class II Siemens Medical Solutions USA, Inc
Jul 10, 2019 CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 9, 2019 MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914 Potential of an open port in the quench venting system when using the optional horizontal outlet ... Class II Siemens Medical Solutions USA, Inc
Jul 9, 2019 MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915 Potential of an open port in the quench venting system when using the optional horizontal outlet ... Class II Siemens Medical Solutions USA, Inc
Jul 9, 2019 MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582 Potential of an open port in the quench venting system when using the optional horizontal outlet ... Class II Siemens Medical Solutions USA, Inc
Jul 9, 2019 MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643 Potential of an open port in the quench venting system when using the optional horizontal outlet ... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2019 SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomograph... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2019 SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tom... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2019 SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomo... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2019 SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2019 SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography sys... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2019 SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography sys... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2019 SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomogra... Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... Class II Siemens Medical Solutions USA, Inc
Jun 20, 2019 Cios Alpha VA20/ VA30 mobile X-Ray systems DAP chamber may be missing an insulating foil Class II Siemens Medical Solutions USA, Inc
Jun 20, 2019 Cios care fusion system DAP chamber may be missing an insulating foil Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 Artis zee biplane MN, Model Number 10094143 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis dFC, Model Number 7412807 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis TC, Model Number 7728350 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis MP, Model Number 5904466 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis dBC, Model Number 5917054 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis FC, Model Number 5904433 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis BC, Model Number 5904649 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis BA, Model Number 5904656 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis dFC, Model Number 7727717 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis TA, Model Number 7007755 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 Artis zee multi, Model Number 10094139 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 Artis zeego, Model Number 10280959 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 Artis zee biplane, Model Number 10094141 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis dTA, Model Number 7008605 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 Artis zee floor, Model Number 10094135 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis dFA, Model Number 7555373 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis dBA, Model Number 7555357 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 Artis zee ceiling, Model Number 10094137 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, 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.