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Browse Device Recalls

702 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 702 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 702 FDA device recalls.

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DateProductReasonClassFirm
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
Jun 12, 2019 AXIOM Artis dBC, Model Number 7728392 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 dMP, Model Number 7555365 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 MN, Model Number 10094142 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 FA, Model Number 5904441 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 dTC, Model Number 7413078 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 6, 2019 Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: ... Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2019 Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model N... Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2019 Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 1... Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2019 Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model ... Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2019 Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Num... Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2019 Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model N... Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2019 Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Nu... Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2019 Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Num... Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2019 Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Numb... Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2019 Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Numbe... Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2019 Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Num... Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2019 Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Numb... Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2019 SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, ... The potential sporadic performance problems may cause scanning workflow interruptions and unexp... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2019 SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, ... The potential sporadic performance problems may cause scanning workflow interruptions and unexp... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2019 SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, ... The potential sporadic performance problems may cause scanning workflow interruptions and unexp... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2019 SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, ... The potential sporadic performance problems may cause scanning workflow interruptions and unexp... Class II Siemens Medical Solutions USA, Inc
May 28, 2019 SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20... The potential sporadic performance problems may result in scanning workflow interruptions and une... 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.