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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

983 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 983 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 983 FDA device recalls.

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DateProductReasonClassFirm
Dec 15, 2015 GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avanc... The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... Class II GE Medical Systems, LLC
Dec 15, 2015 GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia ... The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... Class II GE Medical Systems, LLC
Dec 15, 2015 GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. ... The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... Class II GE Medical Systems, LLC
Dec 15, 2015 GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda... The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... Class II GE Medical Systems, LLC
Dec 15, 2015 GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda ... The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... Class II GE Medical Systems, LLC
Dec 7, 2015 GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Us... Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious ... Class II GE Medical Systems, LLC
Dec 7, 2015 GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex ... Class II GE Medical Systems, LLC
Nov 17, 2015 Merge RadSuite software. The firm name on the label is Merge Healthcare, Har... The values provided from the Pixel Value tool do not appear to be correct, which may result in po... Class II Merge Healthcare, Inc.
Nov 13, 2015 GE Healthcare Optima CL323i Product Usage: The angiographic X-ray system... GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable ... Class II GE Medical Systems, LLC
Nov 13, 2015 GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray syste... GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable ... Class II GE Medical Systems, LLC
Oct 26, 2015 Merge Cardio with software version 10.1 LA. The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customer... Class II Merge Healthcare, Inc.
Oct 26, 2015 Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named Hear... The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customer... Class II Merge Healthcare, Inc.
Oct 23, 2015 GE Healthcare, Revolution CT Scanners. Revolution CT- The system is inte... GE Healthcare has recently become aware of a potential issue with routine head scans on your Revo... Class II GE Medical Systems, LLC
Oct 15, 2015 DR Systems Unity PACS software, now known as Merge Unity PACS software. The software fails to associate to the correct MG image if there are two images for the same view. Class II Merge Healthcare, Inc.
Oct 8, 2015 Merge OrthoCase software. The firm name on the label is Merge Healthcare, H... Measurements in the software are changing after saving a plan with a measurement result, which ma... Class II Merge Healthcare, Inc.
Oct 1, 2015 Merge Cardio software. Merge Cardio is a system intended to be used to ac... Reporting feature times out after inactivity for more than an hour sending the user back to the s... Class II Merge Healthcare, Inc.
Sep 28, 2015 The Centricity PACS-IW with Universal Viewer is a device that displays medica... Inaccurate distance measurements with magnified projection X-ray images. Class II GE Healthcare
Sep 28, 2015 The Centricity Universal Viewer Version is a device that displays medical ima... Inaccurate distance measurements with magnified projection X-ray images. Class II GE Healthcare
Sep 22, 2015 Merge Cardio software. Product Usage: Merge Cardio is a system intended... Users can merge a device import file with an image study that already has a confirmed report, whi... Class II Merge Healthcare, Inc.
Sep 22, 2015 Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the... For sites using the Issuer of Patient ID (IPID), the system will display the study list and image... Class II Merge Healthcare, Inc.
Sep 16, 2015 Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device tha... Images may be missing when a system parameter MapRoute is set to a value greater than 1. Class II GE Healthcare
Aug 31, 2015 GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for di... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 31, 2015 GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 31, 2015 GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 31, 2015 GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR syst... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 31, 2015 GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family ... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 31, 2015 GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging ... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 31, 2015 GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 ... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 11, 2015 Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PA... Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be ... Class II GE Healthcare
Aug 11, 2015 Centricity Universal Viewer Product Usage: The Centricity Universal Viewe... Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be ... Class II GE Healthcare
Jul 23, 2015 Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a... The software is unable to accurately determine the calcium score of scans with a slice thickness ... Class II Merge Healthcare, Inc.
Jul 17, 2015 PET Discovery ST 16 Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Di... Class II GE Healthcare
Jul 17, 2015 PET Discovery LS Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Di... Class II GE Healthcare
Jul 17, 2015 Lightspeed 16 CT Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Di... Class II GE Healthcare
Jul 10, 2015 GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; Ec... A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradien... Class II GE Healthcare
Jun 12, 2015 GE Healthcare, Precision MPi fluoroscopic imaging systems. A reported incident of a monitor that fell from the suspension. A fall of a monitor could result... Class II GE Healthcare
Jun 12, 2015 GE Healthcare Precision RXi Digital system A reported incident of a monitor that fell from the suspension. A fall of a monitor could result... Class II GE Healthcare
Jun 12, 2015 GE Healthcare Precision RXi 23A/32A Analog System A reported incident of a monitor that fell from the suspension. A fall of a monitor could result... Class II GE Healthcare
Jun 12, 2015 GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Flu... The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This m... Class II GE Healthcare
Jun 12, 2015 GE Healthcare Precision 500D Classical R & F system. A reported incident of a monitor that fell from the suspension. A fall of a monitor could result... Class II GE Healthcare
May 31, 2015 The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2... Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to f... Class II Merge Healthcare, Inc.
May 29, 2015 GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiograph... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare

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.