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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

3,505 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,505 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 3,505 FDA device recalls in MA.

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DateProductReasonClassFirm
Sep 17, 2012 Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLa... RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... Class II Siemens Healthcare Diagnostics Inc
Sep 14, 2012 AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identific... Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P... Class II Advandx Inc
Sep 14, 2012 Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4... InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical ... Class II Hologic, Inc.
Sep 14, 2012 AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identific... GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomona... Class II Advandx Inc
Sep 14, 2012 Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1an... Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may b... Class II Hologic, Inc.
Sep 12, 2012 Philips Digital Diagnost with patient carriage Model: 712050 with serial nu... Hook does not securely hold the footplate in vertical position, causing the footplate to disengag... Class II Philips Healthcare Inc.
Sep 11, 2012 Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A bat... HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with ... Class II Philips Healthcare Inc.
Sep 11, 2012 Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) ... BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the... Class II Siemens Healthcare Diagnostics, Inc
Sep 6, 2012 SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRA... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK ... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anc... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK ... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK ... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 22... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anc... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRA... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 22... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRA... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK ... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single ... The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and ... Class II Philips Healthcare Inc.
Aug 29, 2012 T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-hand... During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. Class II SpineFrontier, Inc.
Aug 28, 2012 Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compresso... Inspan Compressors may break at weld causing a loss of compression Class II SpineFrontier, Inc.
Aug 22, 2012 S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223... When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a kno... Class II SpineFrontier, Inc.
Aug 16, 2012 Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product ... Shipped with incorrect software Class II ZOLL Medical Corporation
Aug 15, 2012 Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ ... Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wa... Class II Philips Healthcare Inc.
Aug 14, 2012 Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary ... Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (... Class II Philips Healthcare Inc.
Aug 10, 2012 Capsule Neuron Docking Station, a component in the DataCaptor Connectivity Sy... Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or los... Class II Capsule Tech Inc.
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 7, 2012 ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652... ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t... Class III Siemens Healthcare Diagnostics, Inc
Aug 7, 2012 ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. P... ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t... Class III Siemens Healthcare Diagnostics, Inc
Aug 3, 2012 Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a b... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set wi... Devices leaking at the Y-site Class II Medical Specialties Distributors, Inc.
Aug 3, 2012 Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench t... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a b... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench ... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a b... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a benc... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Jul 25, 2012 Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070.... Essenta DR C-Arm may fall Class II Philips Healthcare Inc.
Jul 25, 2012 Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ... Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board th... Class II Siemens Healthcare Diagnostics, Inc
Jul 24, 2012 DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The de... A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potent... Class II DePuy Spine, 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.