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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

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
Jun 15, 2017 Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001... Boston Scientific (BSC) has received complaints for cracked trays on the Encore device. Class II Boston Scientific Corporation
Jun 15, 2017 PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine der... During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (... Class II TEI Biosciences
Jun 7, 2017 ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Materia... Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol... Class II Siemens Healthcare Diagnostics, Inc
Jun 6, 2017 Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: ... Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio o... Class II Draegar Medical Systems, Inc.
Jun 1, 2017 Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above... Label on the affected devices incorrectly identifies the injection location as "above" the ball... Class II Boston Scientific Corporation
Jun 1, 2017 Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below... Label on the affected devices incorrectly identifies the injection location as "above" the ball... Class II Boston Scientific Corporation
May 31, 2017 Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 7122... Tube arm assembly could fall down due to cracked welding joints Class II Philips Electronics North America Corporation
May 24, 2017 Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in ... When performing the Stitching function on GU60A system, unintended area is exposed to radiation Class II NeuroLogica Corporation
May 23, 2017 Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product U... Underestimates the lead concentration of venous blood samples when the sample is analyzed with th... Class I Magellan Diagnostics, Inc.
May 23, 2017 Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: ... Underestimates the lead concentration of venous blood samples when the sample is analyzed with th... Class I Magellan Diagnostics, Inc.
May 15, 2017 FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is int... The device history record (DHR) was missing its test documentation for final HIPOT (high potentia... Class II Boston Scientific Corporation
May 15, 2017 Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-0... Potential for electric shock in the case of a failure to install the grommets, supplied with the ... Class II Perkinelmer Life Sciences, Inc.
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 ... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 P... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 12, 2017 Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended f... Kit was labeled with the incorrect Expiration Date of April 30, 2019. Class II Terumo Cardiovascular Systems Corp
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product U... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Pro... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 11, 2017 Philips DigitalDiagnost 3.1.x X-Ray System During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential is... Class II Philips Electronics North America Corporation
May 4, 2017 NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865... Manufacturing defect may cause localized heating, which may result in localized skin burn. Class II Philips Electronics North America Corporation
Apr 11, 2017 EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containin... Patient results determined using this calibrator lot might deviate up to 20%. Controls might not ... Class II Medica Corporation
Apr 10, 2017 RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in... Potential Patient Demographic Error with Blank Patient ID Field Class II Siemens Healthcare Diagnostics Inc
Apr 5, 2017 ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog ... Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than... Class II Siemens Healthcare Diagnostics, Inc
Apr 5, 2017 ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 0223... Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than... Class II Siemens Healthcare Diagnostics, Inc
Mar 28, 2017 Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four... It was reported that a set low O2 alarm does not go off although the measured O2 level is below t... Class II Draegar Medical Systems, Inc.
Mar 28, 2017 Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio F... It was reported that a set low O2 alarm does not go off although the measured O2 level is below t... Class II Draegar Medical Systems, Inc.
Mar 28, 2017 Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four... It was reported that a set low O2 alarm does not go off although the measured O2 level is below t... Class II Draegar Medical Systems, Inc.
Mar 24, 2017 Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Sta... ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not ... Class II Dale Medical Products, Inc.
Mar 24, 2017 Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale S... ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not ... Class II Dale Medical Products, Inc.
Mar 22, 2017 UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNI... Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... Class II Philips Electronics North America Corporation
Mar 22, 2017 The following systems are only affected if a Laird chiller is installed (11NC... Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... Class II Philips Electronics North America Corporation
Mar 22, 2017 Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10... Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... Class II Philips Electronics North America Corporation
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 7220404... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 722040... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9.5MM Product Number: 72204045... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 7220404... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 13, 2017 NEODENT CM Intraoral Scanbody, Article Number: 108.139 During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139... Class II Instradent USA, Inc.
Mar 9, 2017 Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection ... Straight PrimaConnex Implants contained Tapered PrimaConnex Implants Class II Keystone Dental Inc
Mar 8, 2017 Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 te... Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the... Class II Siemens Healthcare Diagnostics, Inc
Mar 8, 2017 Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tes... Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the... 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.