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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
Nov 20, 2012 Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System... The Centricity Laboratory removes free-text notes on a master panel when the user deletes the sla... Class II GE Healthcare It
Nov 16, 2012 Centricity Enterprise Archive is a software product for receiving, archiving ... There is a potential for data loss associated with empty path names resulting from HL-7 updates w... Class II Ge Healthcare It
Nov 15, 2012 GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Ar... While merging exams in a test instance, merges carry forward in the production system, when the m... Class II GE Healthcare It
Nov 9, 2012 GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a ... GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data fr... Class II GE Healthcare, LLC
Nov 1, 2012 CADstream software. Product Usage: CADstream is an image processing syst... An incorrect biopsy or missed target could result if the incorrect grid is selected within the ap... Class II Merge Healthcare, Inc.
Oct 16, 2012 Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal s... Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printe... Class II Vital Signs Devices, a GE Healthcare Company
Oct 15, 2012 GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC
Oct 15, 2012 Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitat... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC
Oct 12, 2012 GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical too... GE Healthcare has recently become aware of a potential safety issue associated with the table pa... Class II GE Healthcare, LLC
Oct 2, 2012 Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Commun... GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the... Class II GE Healthcare It
Sep 26, 2012 GE Healthcare Definium 5000/5220493-2 X-Ray System When quickly switching the protocols from AEC to Fixed under the same view, if the user selection... Class II GE Healthcare, LLC
Sep 26, 2012 GE Healthcare Definium 5000 / 5220493 X-Ray System When quickly switching the protocols from AEC to Fixed under the same view, if the user selection... Class II GE Healthcare, LLC
Sep 20, 2012 GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of... It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p... Class II GE Healthcare, LLC
Sep 20, 2012 GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose... It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p... Class II GE Healthcare, LLC
Sep 20, 2012 GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging... It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p... Class II GE Healthcare, LLC
Sep 20, 2012 GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183... GE Healthcare has recently become aware that patient mismatch without a warning message could occ... Class II GE Healthcare, LLC
Sep 20, 2012 GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of ... It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p... Class II GE Healthcare, LLC
Sep 15, 2012 Centricity PACS System versions 3.X and higher and 4.X and higher Product Us... There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam tra... Class II Ge Healthcare It
Aug 16, 2012 GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging syst... GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 21... Class II GE Healthcare, LLC
Aug 13, 2012 GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use ... GE Healthcare became aware of a potential issue related to incorrect image measurement associated... Class II GE Healthcare, LLC
Aug 7, 2012 GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The s... GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx,... Class II GE Healthcare, LLC
Aug 3, 2012 GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Mode... Class II GE Healthcare, LLC
Aug 1, 2012 GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic M... GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... Class II GE Healthcare, LLC
Aug 1, 2012 GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mob... GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... Class II GE Healthcare, LLC
Aug 1, 2012 GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic M... GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... Class II GE Healthcare, LLC
Jul 20, 2012 CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is ... GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. The... Class II GE Healthcare, LLC
Jul 13, 2012 GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. ... GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an ... Class II GE Healthcare, LLC
Jul 12, 2012 GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a mul... GE Healthcare has recently become aware of a number of potential issues associated with the CARE... Class II GE Healthcare, LLC
Jul 10, 2012 Optima XR200amx. Mobile general purpose radiographic imaging of the human he... Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects... Class II GE Healthcare, LLC
Jul 10, 2012 Optima XR220amx Mobile general purpose radiographic imaging of the human h... Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects... Class II GE Healthcare, LLC
Jul 2, 2012 Merge HEMO software. The International Normalized Ratio (INR) value displayed in the study report does not match the v... Class II Merge Healthcare, Inc.
Jun 28, 2012 GE Healthcare, AW Server. Product Usage: . AW Server is a medical softwar... GE Healthcare has recently become aware of a potential safety issue with respect to the Results V... Class II GE Healthcare, LLC
Jun 26, 2012 GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monito... GE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom ... Class II GE Healthcare, LLC
Jun 26, 2012 GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal... Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak In... Class I GE Healthcare, LLC
Jun 15, 2012 Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device tha... Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety ri... Class II Ge Healthcare It
Jun 13, 2012 GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monit... GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. The... Class II GE Healthcare, LLC
Jun 13, 2012 GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking st... GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor.... Class II GE Healthcare, LLC
Jun 12, 2012 GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 201... GE Healthcare has become aware through complaints of a potential safety issue with its Invasive B... Class II GE Healthcare, LLC
Jun 8, 2012 GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without ... GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Prod... Class II GE Healthcare, LLC
Jun 8, 2012 GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnos... GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Prod... Class II GE Healthcare, LLC
Jun 8, 2012 GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR ... GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Prod... Class II GE Healthcare, LLC
May 29, 2012 Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 a... GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mis... Class II GE Healthcare, LLC
May 25, 2012 GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Vie... Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safe... Class II GE Healthcare, LLC
May 24, 2012 GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advanta... GE Healthcare has become aware of an issue associated with the magnification images acquired on n... Class II GE Healthcare, LLC
May 24, 2012 GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.... GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol o... Class II GE Healthcare, LLC
May 24, 2012 AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 516009... It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, t... Class II GE Healthcare, LLC
May 24, 2012 GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 an... GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdv... Class II GE Healthcare, LLC
May 24, 2012 GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View... GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT... Class II GE Healthcare, LLC
Apr 23, 2012 GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Produ... GE Healthcare has recently become aware of a potential issue due to image flip in frequency encod... Class II GE Healthcare, LLC
Apr 19, 2012 The GE Centricity Web; Software Version 3.0x, is intended for use under the d... GE Healthcare has become aware of an issue associated with rejected images using the WADO protoco... Class II Ge Healthcare It

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.