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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

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

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Browse Device Recalls

3,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,419 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 3,419 FDA device recalls in MA.

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DateProductReasonClassFirm
Dec 21, 2016 Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Produc... AutoDELFIA System with Version 3.0 Software: Potential plate loading failures Class III PerkinElmer Health Sciences, Inc.
Dec 21, 2016 Fresenius 2008T Series Hemodialysis System When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change i... Class II Fresenius Medical Care Renal Therapies Group, LLC
Dec 21, 2016 Fresenius 2008K2 Series : Hemodialysis System When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change i... Class II Fresenius Medical Care Renal Therapies Group, LLC
Dec 21, 2016 Fresenius 2008K@home Series : Hemodialysis System When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change i... Class II Fresenius Medical Care Renal Therapies Group, LLC
Dec 16, 2016 MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy An error can occur causing Delta corrections to be lost when one setup field is closed and anothe... Class II Mevion Medical Systems, Inc.
Dec 15, 2016 TVC Imaging System model TVC-MC9 , for the near-infrared examination of coron... Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some... Class II Infraredx, Inc.
Dec 9, 2016 Velara Generator with an old Firmware version used with Philips Allura Xper S... System may lock up. Class II Philips Electronics North America Corporation
Dec 9, 2016 Velara Generator with an old Firmware version used with the Philips Integris ... System may lock up. Class II Philips Electronics North America Corporation
Dec 1, 2016 Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray im... Due to a production error, screws were not tightened to specified torque. These screws may come ... Class II Philips Electronics North America Corporation
Dec 1, 2016 Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular ... Due to a production error, screws were not tightened to specified torque. These screws may come ... Class II Philips Electronics North America Corporation
Dec 1, 2016 Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing tran... Possibility that a patient or user may be exposed to a very small level of touch current. Class II Philips Electronics North America Corporation
Dec 1, 2016 Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray im... Due to a production error, screws were not tightened to specified torque. These screws may come ... Class II Philips Electronics North America Corporation
Dec 1, 2016 Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Softwar... Issue may cause eReports to consume an excessive amount of disk space causing the software to sto... Class II PerkinElmer Health Sciences, Inc.
Dec 1, 2016 Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-r... Due to a production error, screws were not tightened to specified torque. These screws may come ... Class II Philips Electronics North America Corporation
Nov 23, 2016 Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant ac... Drills cannot be inserted into handpiece due to tolerance specification not met Class II Straumann Manufacturing, Inc.
Nov 23, 2016 Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant ... Drills cannot be inserted into handpiece due to tolerance specification not met Class II Straumann Manufacturing, Inc.
Nov 23, 2016 Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and d... During use, the unit could separate un-expectantly. This failure would allow the patient's arm t... Class II Allen Medical Systems, Inc.
Nov 21, 2016 GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indic... Endotoxin values from testing of retains slightly exceeded the established specification. Class II Tepha Incorporated
Nov 16, 2016 DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrat... Class III PerkinElmer Health Sciences, Inc.
Oct 31, 2016 ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The... iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm). Class II ConforMIS, Inc.
Oct 31, 2016 MEVION S250 Product Usage: Proton Radiation Therapy Completing Setup Without Program Move Complete Can Cause An Isocenter Error Class II Mevion Medical Systems, Inc.
Oct 28, 2016 SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. ... Breach in sterile barrier compromising product sterility Class II Hologic, Inc
Oct 27, 2016 Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analy... Possible unintentional x-ray emission after users attempt early termination of the sequence. Class II Olympus Scientific Solutions Americas
Oct 21, 2016 MEVION S250 Product Usage: Proton Radiation Therapy System Recovery of Incorrect Isocenter -operational change Class II Mevion Medical Systems, Inc.
Oct 20, 2016 MEVION S250 Product Usage: Proton Radiation Therapy System Software defect:2D projection of contours in Verity. The defect causes structures to appear off f... Class II Mevion Medical Systems, Inc.
Oct 19, 2016 ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur an... CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the A... Class II Siemens Healthcare Diagnostics, Inc
Oct 19, 2016 ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur an... CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the A... Class II Siemens Healthcare Diagnostics, Inc
Oct 18, 2016 ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Ca... Mislabeled: incorrect serial number on the F4 A/P cut guide iJig. Class II ConforMIS, Inc.
Oct 14, 2016 OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigati... Incorrect lot number on outer kit Class III OMNI LIFE SCIENCE
Oct 13, 2016 PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677.... Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for... Class II PerkinElmer, Inc
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCR... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW ... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCRE... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SC... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCRE... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING ... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCR... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 5, 2016 Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test) Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias wit... Class II Siemens Healthcare Diagnostics, Inc
Oct 5, 2016 Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test) Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias wit... Class II Siemens Healthcare Diagnostics, Inc
Sep 22, 2016 Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number:... O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigate... Class II Medtronic Navigation, Inc.-Littleton
Sep 19, 2016 Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product... Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and De... Class II Philips Electronics North America Corporation
Sep 19, 2016 Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (... Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and De... Class II Philips Electronics North America Corporation
Sep 19, 2016 Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GH... Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and De... Class II Philips Electronics North America Corporation
Sep 15, 2016 Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 ... Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match t... Class II Keystone Dental Inc
Sep 2, 2016 Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812,... Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 4... Class III Siemens Healthcare Diagnostics Inc
Sep 2, 2016 Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, ... Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 4... Class III Siemens Healthcare Diagnostics Inc
Aug 26, 2016 HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A The handle can separate from the MRx housing due to breakage of mounts on the rear case. Class II Philips Electronics North America Corporation
Aug 22, 2016 Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast bi... Incorrect label on the Sertera Biopsy Kit Class II Hologic, Inc
Aug 12, 2016 PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732... A defect component of the Compano reader power supply can cause the power supply to burn and some... Class II Philips Electronics North America Corporation
Aug 11, 2016 Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 1... There is a potential for the first and/or last name of one patient to be printed with Patient ID ... Class II Siemens Healthcare Diagnostics 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.