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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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Browse Device Recalls

1,382 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,382 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 1,382 FDA device recalls in NY.

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DateProductReasonClassFirm
May 27, 2016 Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring de... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For color... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For colori... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For colori... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For colo... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For colorin... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring d... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For c... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 26, 2016 ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 108197... Eight (8) issues were identified which may affect the results generated by the system software ve... Class II Siemens Healthcare Diagnostics, Inc.
May 24, 2016 VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used ... Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VI... Class III Ortho-Clinical Diagnostics
May 18, 2016 VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Uniqu... Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be gene... Class II Ortho-Clinical Diagnostics
May 18, 2016 Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Bi... A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener... Class II Conmed Corporation
May 18, 2016 Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtche... A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener... Class II Conmed Corporation
May 18, 2016 Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable... A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener... Class II Conmed Corporation
May 18, 2016 Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10'... A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener... Class II Conmed Corporation
May 18, 2016 Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.0... A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener... Class II Conmed Corporation
May 16, 2016 enGen Laboratory Automation System, Product Code engen, Software Versions enG... If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numeri... Class III Ortho-Clinical Diagnostics
Apr 28, 2016 IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ... Possible presence of foreign material (rust). Class II CMP Industries, Llc
Apr 28, 2016 ADVIA Centaur XPT Immunoassay System The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) ... Class II Siemens Healthcare Diagnostics, Inc.
Apr 28, 2016 IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454... Possible presence of foreign material (rust). Class II CMP Industries, Llc
Apr 22, 2016 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the ep... There is a possibility that the needles may have the potential to skive a catheters outer coatin... Class II Epimed International, Inc.
Apr 19, 2016 The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunctio... There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will pr... Class III Ortho-Clinical Diagnostics
Apr 15, 2016 IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insu... 24 minutes of incubation is required prior to processing patient samples and for the pretreatment... Class II Siemens Healthcare Diagnostics, Inc.
Apr 15, 2016 CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490... Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospita... Class II Carestream Health Inc
Apr 15, 2016 CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1... Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospita... Class II Carestream Health Inc
Apr 6, 2016 VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in... Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... Class II Ortho-Clinical Diagnostics
Apr 6, 2016 VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifi... Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... Class II Ortho-Clinical Diagnostics
Mar 30, 2016 ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710,... The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two ina... Class III Siemens Healthcare Diagnostics, Inc.
Mar 30, 2016 AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./... The product lot did not meet sterility requirements based on FDA sampling and analysis. Class II Amd-Ritmed, Inc.
Mar 21, 2016 AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870,... Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the pr... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Mar 21, 2016 Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Us... Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the pr... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Mar 17, 2016 enGen (TM) Laboratory Automation System configured with Thermo Scientific Rec... The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may l... Class II Ortho-Clinical Diagnostics
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Ki... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M0014... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN ... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company

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.