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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

2,057 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,057 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 2,057 FDA device recalls in NJ.

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DateProductReasonClassFirm
Mar 9, 2015 Fujifilm Endoscope Model ED-530XT Product Usage: This product is a me... Fujifilm is reporting a corrective action due to an FDA inspection. Class II Fujifilm Medical Systems U.S.A., Inc.
Mar 9, 2015 Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 ... Fujifilm is conducting a corrective action due to an FDA inspection. Class II Fujifilm Medical Systems U.S.A., Inc.
Mar 5, 2015 Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are conti... The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... Class II Siemens Medical Solutions Diagnostics
Mar 5, 2015 HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Produc... A potential issue was detected that could result in blood leakage from the gas outlet port in all... Class II Maquet Cardiovascular Us Sales, Llc
Mar 5, 2015 Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox... A potential issue was detected that could result in blood leakage from the gas outlet port in all... Class II Maquet Cardiovascular Us Sales, Llc
Mar 5, 2015 Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi ... The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... Class II Siemens Medical Solutions Diagnostics
Mar 5, 2015 Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi... The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... Class II Siemens Medical Solutions Diagnostics
Mar 5, 2015 Direct Water feed Kit, Catalog#10373222 The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... Class II Siemens Medical Solutions Diagnostics
Mar 5, 2015 Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are ... The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... Class II Siemens Medical Solutions Diagnostics
Mar 5, 2015 Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 sy... The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... Class II Siemens Medical Solutions Diagnostics
Mar 2, 2015 The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part numb... Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the... Class II Maquet Cardiovascular Us Sales, Llc
Feb 27, 2015 Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extend... Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 ... Class II Stryker Howmedica Osteonics Corp.
Feb 19, 2015 BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #3... Becton Dickinson received an elevated number of complaints for blood or infusate/medication leaka... Class II Becton Dickinson & Company
Feb 12, 2015 Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Dist... Potential for weld disassociation of the cross pin, which could lead to loose or disassociated tr... Class II Stryker Howmedica Osteonics Corp.
Feb 11, 2015 Milestone Wand STA Handpiece for the delivery of local anesthesia to dental t... Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the ST... Class III Milestone Scientific, Inc.
Feb 4, 2015 NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Siz... One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed. Class II Zimmer Trabecular Metal Technology, Inc.
Feb 3, 2015 LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4... Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (p... Class II Stryker Howmedica Osteonics Corp.
Jan 30, 2015 Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) Power supply malfunction complaints related to suboptimal thermal management. Class II Maquet Datascope Corp - Cardiac Assist Division
Jan 23, 2015 Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection ... An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) whic... Class II Mindray DS USA, Inc. dba Mindray North America
Jan 13, 2015 cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA a... False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mu... Class III Roche Molecular Systems, Inc.
Jan 13, 2015 Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medica... Tthe medical monitor has either not turned on or has lost image during clinical use. Class II Sony Medical Systems
Jan 12, 2015 Servo-I ventilator system CO2 analyzer. Part number 65 23 588. A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 anal... Class II Maquet Cardiovascular Us Sales, Llc
Dec 19, 2014 BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Inj... The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe. Class II Becton Dickinson & Company
Dec 18, 2014 cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Inten... cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS C... Class III Roche Molecular Systems, Inc.
Dec 16, 2014 CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and... Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration u... Class II Maquet Datascope Corp - Cardiac Assist Division
Dec 15, 2014 Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E ... Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-... Class II Stryker Howmedica Osteonics Corp.
Dec 4, 2014 DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone vo... The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above ma... Class II Musculoskeletal Transplant Foundation, Inc.
Dec 2, 2014 NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibi... During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial ... Class II Zimmer Trabecular Metal Technology, Inc.
Nov 11, 2014 Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-53... A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleev... Class II Ebi, Llc
Nov 7, 2014 Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxyg... Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since Oc... Class II Integra LifeSciences Corp.
Nov 6, 2014 Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace th... Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CM... Class II Integra LifeSciences Corp.
Nov 5, 2014 Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coatin... Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for ... Class II Maquet Cardiovascular Us Sales, Llc
Oct 24, 2014 Integra Titan Reverse Shoulder System right and left head cutting templates, ... A single lot of left and a single lot of right Reverse Shoulder System cutting templates were man... Class II Integra LifeSciences Corp.
Oct 17, 2014 Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxid... Cardiohelp- i System may have a software issue that can potentially result in an erroneous displa... Class II Maquet Cardiovascular Us Sales, Llc
Oct 17, 2014 Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethic... Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expec... Class II Ethicon, Inc.
Oct 9, 2014 BD Insyte Autoguard Catheter An active safety engineered peripheral IV cat... BD Insyte Autoguard may have potential damage along the body of the catheter. Class II Becton Dickinson & Company
Oct 8, 2014 Cypher MIS Screw System-The system includes screws, various types and sizes o... Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is ... Class II Ebi, Llc
Oct 6, 2014 Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blanket... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) P... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes ... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes ... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002X... Stryker has received a complaint from customers relating to a fracture during the use of the Spec... Class II Stryker Spine
Oct 6, 2014 Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radi... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blanket... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Ra... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product U... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the... Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monito... Class II Mindray DS USA, Inc. dba Mindray North America
Oct 6, 2014 Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Si... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usa... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, 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.