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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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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

4,686 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,686 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 4,686 FDA device recalls in CA.

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DateProductReasonClassFirm
Sep 11, 2014 ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System... Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of ... Class II Intuitive Surgical, Inc.
Aug 29, 2014 Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS4... Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has d... Class II Dako North America Inc.
Aug 26, 2014 The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm... The expiration date of the bar code on the envelope label did not match the expiration date next ... Class II MAST Biosurgery USA, Inc
Aug 25, 2014 Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises dilu... Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated plate... Class II Beckman Coulter Inc.
Aug 21, 2014 UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices use... Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may... Class II Beckman Coulter Inc.
Aug 19, 2014 Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD... An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damag... Class II St Jude Medical Cardiac Rhythm Management Division
Aug 19, 2014 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow C... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 19, 2014 STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 C... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 19, 2014 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Contr... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 19, 2014 STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 C... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 18, 2014 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provi... Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by th... Class II Varian Medical Systems, Inc.
Aug 15, 2014 Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174A... Medtronic has decided to discontinue production and distribution of this low-volume product. Class II Medtronic Cardiovascular Surgery-the Heart Valv...
Aug 13, 2014 V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (... Reports of deterioration of material covering the articulating section of the V5Ms transesophagea... Class II Siemens Medical Solutions USA, Inc.
Aug 13, 2014 Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; S... Internal testing had identified a potential breach to the sterile barrier that may impact the ste... Class II Volcano Corporation
Aug 11, 2014 ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX P... Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability c... Class II Horiba Instruments, Inc dba Horiba Medical
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 6, 2014 iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only... One lot may not have been properly sealed, resulting in a non-sterile device. Class II Ellex iScience, Inc.
Aug 5, 2014 CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes a... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Aug 5, 2014 Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefil... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Aug 5, 2014 Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefill... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Jul 28, 2014 Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina M... A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.... Class II Illumina Inc
Jul 24, 2014 Philips IntelliSpace PACS 4.4 image management systems performs digital image... A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information... Class II Philips Healthcare Informatics, Inc.
Jul 21, 2014 Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Us... Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue t... Class II Medtronic MiniMed Inc.
Jul 18, 2014 BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete ... The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be ... Class III BD Biosciences, Systems & Reagents
Jul 18, 2014 Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flu... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stri... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 0... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Mac... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device a... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and ... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valv... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 11, 2014 FlowCOUPLER. An implantable device that is used to detect blood flow in ves... Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some un... Class II Baxter Healthcare Corporation
Jul 1, 2014 InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagno... Product was distributed without 510(k) approval. Class II Biogenex Laboratories, Inc.
Jun 30, 2014 PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment ... RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility th... Class II Ra Medical Systems Inc
Jun 26, 2014 Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the S... Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that ... Class II Alphatec Spine, Inc.
Jun 25, 2014 Merci Retriever Intended to restore blood flow in the neurovasculature by ... Merci Retrievers were shipped to US customers past their expiration date, even though they were l... Class II Concentric Medical Inc
Jun 25, 2014 Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentrat... The case label correctly states partial rebreather but the insert label incorrectly states non-re... Class II Salter Labs
Jun 25, 2014 Essential NEO, Audio/Visual Integration Unit An audio/visual integration u... KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable cou... Class II Karl Storz Endoscopy
Jun 20, 2014 Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Steril... Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially... Class II Stryker Endoscopy
Jun 17, 2014 SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 1006... CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a... Class II CareFusion 303, Inc.
Jun 17, 2014 C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilog... Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerator... Class II Varian Medical Systems, Inc.
Jun 16, 2014 Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a ... Class II Medtronic MiniMed 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.