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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

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
Mar 31, 2016 X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray h... Report of unintentional movement of table to reverse tilting. Class II Shimadzu Medical Systems
Mar 31, 2016 CF InPlex ASR Card; Catalog Number: 95-0501. Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive ... Class II Hologic, Inc
Mar 31, 2016 Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog... Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some ... Class III Biocare Medical, LLC
Mar 31, 2016 BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucou... One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% differenc... Class II Becton, Dickinson and Company, BD Biosciences
Mar 31, 2016 Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432. Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive ... Class II Hologic, Inc
Mar 31, 2016 Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411... St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the... Class II St Jude Medical Inc.
Mar 28, 2016 PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; H... When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inle... Class II Stryker Endoscopy
Mar 25, 2016 EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi syst... Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software... Class II Intuitive Surgical, Inc.
Mar 25, 2016 Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. ... Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose a... Class II Hansen Medical Inc
Mar 24, 2016 Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, ... The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the s... Class II CareFusion 303, Inc.
Mar 24, 2016 CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematolo... Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality ... Class II Abbott Laboratories
Mar 21, 2016 Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and det... Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GB... Class II Hardy Diagnostics
Mar 21, 2016 GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR... The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. Class II Stryker Neurovascular
Mar 21, 2016 GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033... The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. Class II Stryker Neurovascular
Mar 18, 2016 BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro ... The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect stor... Class III Becton, Dickinson and Company, BD Biosciences
Mar 16, 2016 da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & a... Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.... Class II Intuitive Surgical, Inc.
Mar 16, 2016 da Vinci S Surgical System (IS4000) user manual English and OUS. Product U... Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.... Class II Intuitive Surgical, Inc.
Mar 16, 2016 iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0... A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database th... Class II Optovue, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Dian... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No.... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Dia... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 4, 2016 The Spectra-System Dental Implant 2008 system is comprised of dental implant ... Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees d... Class II Implant Direct Sybron Manufacturing, LLC
Feb 29, 2016 RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instr... There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point ... Class II Nidek Inc
Feb 25, 2016 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip ... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip ... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock P... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Dr... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoL... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Cham... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 24, 2016 Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, a... During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS ex... Class II Toshiba American Medical Systems Inc
Feb 24, 2016 PureWick External Catheter for Women-Wick Product Usage: A flexible, con... PureWick is recalling external catheter for women Wicks because the labeling did not contain the ... Class II Purewick Corporation
Feb 23, 2016 Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receive... Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... Class I Dexcom Inc
Feb 23, 2016 Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT2... Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... Class I Dexcom Inc
Feb 23, 2016 Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Bl... Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... Class I Dexcom Inc
Feb 23, 2016 Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), ... Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... Class I Dexcom Inc
Feb 23, 2016 Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiv... Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... Class I Dexcom Inc
Feb 23, 2016 Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Rec... Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... Class I Dexcom Inc
Feb 22, 2016 Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#:... Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the pac... Class II Innovative Ophthalmic Products, Inc
Feb 19, 2016 ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are di... Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (ve... Class II Horiba Instruments Inc
Feb 19, 2016 Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discr... Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (ve... Class II Horiba Instruments Inc
Feb 19, 2016 CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospec... Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink i... Class II Medtronic MiniMed Inc.
Feb 16, 2016 da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touch... Class II Intuitive Surgical, Inc.
Feb 15, 2016 Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007 CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages a... Class II CareFusion 303, Inc.
Feb 12, 2016 Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092 CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may ca... Class II CareFusion 303, Inc.
Feb 11, 2016 MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 ... Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software... Class II Beckman Coulter 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.