Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

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

Infrastructure

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

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

Browse Device Recalls

4,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,602 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 4,602 FDA device recalls in CA.

Clear
DateProductReasonClassFirm
Jan 16, 2019 daVinci Harmonic ACE Curved Shears During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Ha... Class II Intuitive Surgical, Inc.
Jan 16, 2019 Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a... Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen l... Class II Edwards Lifesciences, LLC
Jan 14, 2019 SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product U... In these units, the brake is usually released by gripping the drive handle and applied by letting... Class II Shimadzu Medical Systems Usa Com
Jan 14, 2019 TRINIAS for diagnostic imaging and interventional procedures in cardiac angio... Two issues: Event 1: Normal operation of the device is to power up the device in the morning, ... Class II Shimadzu Medical Systems Usa Com
Jan 14, 2019 BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is ... Normal operation of the device is to power up the device in the morning, register the first patie... Class II Shimadzu Medical Systems Usa Com
Jan 11, 2019 Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (l... Shelf life of the product may be reduced due to degradation of the assay. Class III Lin-Zhi International Inc
Jan 9, 2019 SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 Due to a complaint received and internal investigation it was determined that implant vials were ... Class II Implant Direct Sybron Manufacturing LLC
Jan 9, 2019 Insufflation tubing to be used with varies insufflator units. REF 031200-10; ... The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable... Class III Karl Storz Endoscopy
Jan 3, 2019 icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed Sy... There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate Class I ICU Medical, Inc.
Jan 2, 2019 BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 66... A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 ... Class III Becton, Dickinson and Company, BD Biosciences
Dec 26, 2018 Eclipse(TM) Treatment Planning System with Proton Convolution Superposition a... There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Super... Class II Varian Medical Systems, Inc.
Dec 21, 2018 Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Produc... These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... Class I Edwards Lifesciences, LLC
Dec 21, 2018 Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product... These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... Class I Edwards Lifesciences, LLC
Dec 21, 2018 Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product ... These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... Class I Edwards Lifesciences, LLC
Dec 21, 2018 Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of... These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... Class I Edwards Lifesciences, LLC
Dec 12, 2018 Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 4... Unintentional shifting of the tip insulation of the firm's electrosurgical probes. Class II Applied Medical Resources Corp
Dec 12, 2018 GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with... Unintentional shifting of the tip insulation of the firm's electrosurgical probes. Class II Applied Medical Resources Corp
Dec 10, 2018 Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. The incorrect sensor was used in the assembly of the camera in the scanner instrument which can p... Class II Leica Biosystems Imaging, Inc.
Dec 7, 2018 Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diamet... The incorrect outer carton box was used for the product. Class II Spectranetics Corporation
Dec 6, 2018 VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE)... VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may ex... Class II Carl Zeiss Meditec, Inc.
Dec 5, 2018 The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to ... When racks are front-loaded onto the sample presentation unit while samples from the automation l... Class II Beckman Coulter Inc.
Dec 5, 2018 UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that ... When racks are front-loaded onto the sample presentation unit while samples from the automation l... Class II Beckman Coulter Inc.
Dec 4, 2018 Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-... This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments ar... Class II Intuitive Surgical, Inc.
Dec 3, 2018 Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Ste... Incorrect default dose and dose increments may be transmitted to the controller if the catheter R... Class II PENTAX of America Inc
Dec 3, 2018 Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX... Incorrect default dose and dose increments may be transmitted to the controller if the catheter R... Class II PENTAX of America Inc
Dec 3, 2018 C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 ... The Controller does not detect overpressure in the balloon during the application of non-dosing p... Class II PENTAX of America Inc
Dec 3, 2018 Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile... Incorrect default dose and dose increments may be transmitted to the controller if the catheter R... Class II PENTAX of America Inc
Nov 28, 2018 ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platfor... The peek part was loose on the titanium base of the device which could result in it falling into ... Class II Implant Direct Sybron Manufacturing, LLC
Nov 28, 2018 ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platfor... The peek part was loose on the titanium base of the device which could result in it falling into ... Class II Implant Direct Sybron Manufacturing, LLC
Nov 27, 2018 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... Class II ICU Medical, Inc.
Nov 27, 2018 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... Class II ICU Medical, Inc.
Nov 27, 2018 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... Class II ICU Medical, Inc.
Nov 21, 2018 da Vinci X Surgical System Due to a manufacturing variation in the arm that can result in a persistent recoverable fault err... Class II Intuitive Surgical, Inc.
Nov 21, 2018 da Vinci Xi Surgical System Due to a manufacturing variation in the arm that can result in a persistent recoverable fault err... Class II Intuitive Surgical, Inc.
Nov 19, 2018 St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. ... The device is unable to pair with the mobile app due to the device incorrectly determining the ce... Class II Abbott
Nov 13, 2018 Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE ... Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter pa... Class II Stryker Neurovascular
Nov 13, 2018 Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVisi... During a post approval study the firm found there was an increased risk of corneal haze following... Class I RVO 2.0, INC
Nov 9, 2018 AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25... Beckman Coulter has identified a case where a customer using the microltiterplate kit option with... Class II Beckman Coulter Inc.
Nov 9, 2018 TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter ... A limited number of lenses may be mislabeled with the incorrect diopter power. Class II Tekia, Inc.
Nov 7, 2018 Philips Volcano FFR software used in the following systems connected to the M... Interoperability issue that affects certain systems that use the recalled software when it is con... Class II Volcano Corporation
Oct 30, 2018 Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A... Potential for chemical analyzer to report abnormal results due to an interference with triglyce... Class II Horiba Instruments Incorporated
Oct 26, 2018 Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, ... packaging error; An internal QA inspection revealed that a incorrect healing collar could have ... Class II Implant Direct Sybron Manufacturing, LLC
Oct 25, 2018 da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch The instrument drape may tear while draping the Patient Side Cart presenting a breach in the ster... Class II Intuitive Surgical, Inc.
Oct 23, 2018 The da Vinci SP surgical system is made of three main components: the Surgeon... The firm became aware of a problem with the surgical system where the cannula mount button may be... Class II Intuitive Surgical, Inc.
Oct 18, 2018 iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. T... Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitiv... Class II Beckman Coulter Inc.
Oct 17, 2018 Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0... Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to... Class II Volcano Corporation
Oct 17, 2018 Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0... Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to... Class II Volcano Corporation
Oct 16, 2018 The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX E... Under certain fault conditions, the existing design may expose the operator to a hazardous voltag... Class II Carl Zeiss Meditec, Inc.
Oct 16, 2018 Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version... software malfunction; It was found when a user performs radiography using the wireless flat pane... Class II Canon Medical System, USA, INC.
Oct 5, 2018 Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 u... Potential for leakage due to defect in the thermoset check valve component. Class II ICU Medical, 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.