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Vehicle Safety

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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

1,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,550 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 1,550 FDA device recalls in 2012.

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DateProductReasonClassFirm
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 Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with O... There were reports that a certain combination of key presses will cause the module to disconnect ... Class II Spacelabs Healthcare, Llc
Jun 12, 2012 Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr The hex bolt head might shear and cause the axle plate to detach from the lower frame of the whee... Class II Pdg Product Design Group Inc
Jun 12, 2012 Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usag... Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, th... Class II Teleflex Medical
Jun 12, 2012 Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc... Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium... Class II Carestream Health, Inc.
Jun 12, 2012 QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000... It has come to firm's attention that, in some rare cases, the blood outlet connector on some mode... Class II Maquet Cardiovascular Us Sales, 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 11, 2012 Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold un... This letter is to notify you that several of our sterile screw products are being voluntarily rec... Class II Tedan Surgical Innovations Llc
Jun 11, 2012 Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutt... Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a ca... Class II The Anspach Effort, Inc.
Jun 11, 2012 Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome.... Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a ca... Class II The Anspach Effort, Inc.
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 Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's T... Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear t... Class II Merit Medical Systems, Inc.
Jun 8, 2012 NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system... One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz... Class II Philips And Neusoft Medical Systems Co., Ltd.
Jun 8, 2012 Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 070... Stryker has received two reports of serious injury as a result of tissue damage associated with t... Class I Stryker Instruments Div. of Stryker Corporation
Jun 8, 2012 Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste M... Stryker has received two reports of serious injury as a result of tissue damage associated with t... Class I Stryker Instruments Div. of Stryker Corporation
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 Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in t... Stryker has received two reports of serious injury as a result of tissue damage associated with t... Class I Stryker Instruments Div. of Stryker Corporation
Jun 8, 2012 MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. ... Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ whe... Class II Impac Medical Systems Inc
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
Jun 8, 2012 Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover ... Stryker has received two reports of serious injury as a result of tissue damage associated with t... Class I Stryker Instruments Div. of Stryker Corporation
Jun 7, 2012 EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informa... There is a potential for the EasyLink system to display and transmit to the Laboratory Informatio... Class II Siemens Healthcare Diagnostics, Inc.
Jun 7, 2012 Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Inject... Arrow is recalling the product due to the possibility of voids in the catheter hub which could le... Class II Arrow International Inc
Jun 7, 2012 Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classi... The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation anal... Class II Siemens Healthcare Diagnostics, Inc.
Jun 7, 2012 Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502... Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058... Class III Siemens Healthcare Diagnostics, Inc.
Jun 7, 2012 Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley Cit... Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadve... Class III Integra LifeSciences Corp. d.b.a. Integra Pain ...
Jun 6, 2012 ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - ... The firm recalled because the glucose measurements from a patient sample that the customer felt w... Class II Sendx Medical Inc
Jun 6, 2012 AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Do... Internal data identified a molding defect in the 15 mm O.D. / I.D. MiniSpacer meter dose inhaler ... Class II Thayer Medical Corporation
Jun 6, 2012 Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC... Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the... Class II Edwards Lifesciences, LLC
Jun 6, 2012 Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 ... Unit fails to power up, resulting in an equipment alarm Class II Zoe Medical Incorporated
Jun 6, 2012 Siemens syngo.plaza radiological image processing system. Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the... Class II Siemens Medical Solutions USA, Inc
Jun 5, 2012 PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrume... Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove ... Class II Zimmer, Inc.
Jun 5, 2012 Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle hand... Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been ... Class II Zimmer, Inc.
Jun 5, 2012 Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use ... The Tyvek pouch label for this device states: 'with holster'; however, this product does not com... Class II PSC Industries Inc
Jun 5, 2012 Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Ele... The carton label for this device has the manufacturer symbol where the expiration date symbol sho... Class II PSC Industries Inc
Jun 5, 2012 Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight h... Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been ... Class II Zimmer, Inc.
Jun 4, 2012 Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems... Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reducti... Class II Leica Microsystems, Inc.
Jun 4, 2012 Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal C... The deflector may not move freely on the ventricular catheter. The deflector comes pre-positione... Class II Aesculap, Inc.
Jun 1, 2012 Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipol... Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel ... Class II PSC Industries Inc
Jun 1, 2012 Sysmex XE-2100 Automated Hematology System; an automated differential cell co... There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... Class II Sysmex America, Inc.
Jun 1, 2012 T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a... The clear tape, that is intended to aid in the prevention of patients fluids from contacting the... Class II Stryker Instruments Div. of Stryker Corporation
Jun 1, 2012 Sysmex XE-5000 Automated Hematology System; an automated differential cell co... There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... Class II Sysmex America, Inc.
Jun 1, 2012 I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T ... I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Ca... Class II I-Flow LLC
Jun 1, 2012 I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089... I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Ca... Class II I-Flow LLC
Jun 1, 2012 Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use S... Firm officials reported to CIN-DO that the outer carton label of this sterile, single use device ... Class II PSC Industries Inc
Jun 1, 2012 Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar... Firm officials reported to CIN-DO that their Electrosurgical Monopolar Reusable Bayonet Forceps ... Class II PSC Industries Inc
Jun 1, 2012 Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irri... Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel ... Class II PSC Industries Inc
Jun 1, 2012 CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho... The recall was initiated because Advanced Sterilization Products has discovered instances of miss... Class II Advanced Sterilization Products
Jun 1, 2012 Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipo... Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in tha... Class II PSC Industries Inc
Jun 1, 2012 Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Us... Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel ... Class II PSC Industries 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.