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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

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

Clear
DateProductReasonClassFirm
Jul 1, 2019 daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UD... The firm became aware of a manufacturing variation in which black and green reloads in select Sta... Class II Intuitive Surgical, Inc.
Jul 1, 2019 STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:Th... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performi... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Drivelin... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit i... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jun 28, 2019 Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An intro... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Healt... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Healt... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 28, 2019 Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in se... Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, cata... Class II Sentinel CH SpA
Jun 28, 2019 Workstation, G2, Configured (P/N 000-0241) Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the... Class II Intellijoint Surgical, Inc.
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar ... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 28, 2019 Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN:... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 ... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 28, 2019 MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasm... Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, cata... Class II Sentinel CH SpA
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar C... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 28, 2019 Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar C... 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... Class II Degania Silicone, Ltd.
Jun 28, 2019 MAC VU360, Model Number 2030360-001, Electrocardiograph Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit ... Class II GE Healthcare, LLC
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-523 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT... The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825 The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun... Class II Inter-Med Llc
Jun 27, 2019 AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .01... The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID... Class II Angiodynamics, Inc.
Jun 27, 2019 N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative de... Iincreased (falsely elevated) Albumin results compared to expected results Class II Siemens Healthcare Diagnostics, Inc.
Jun 27, 2019 Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850 The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun... Class II Inter-Med Llc
Jun 27, 2019 Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-... The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun... Class II Inter-Med Llc
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-722 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes... The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun... Class II Inter-Med Llc
Jun 27, 2019 MiniMed Paradigm Model 511 Insulin Pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 P... EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers. Class III Baxter Healthcare Corporation
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, RE... The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun... Class II Inter-Med Llc
Jun 27, 2019 MiniMed Paradigm Insulin pump, model number MMT-712 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 MiniMed Paradigm 512 Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes... The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun... Class II Inter-Med Llc
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-522 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product ... The exposed area of fluo exams possibly does not match the active area of the detector within spe... Class II Agfa N.V.
Jun 27, 2019 MiniMed Insulin Pump, model # MMT-508 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PE... It has been determined that some Pedicle system screw identified as 45mm long have an actual len... Class II Medicrea International
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-723 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syri... The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun... Class II Inter-Med Llc
Jun 26, 2019 IMRIS MR/X-ray head fixation device, Model HFD200 Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond ... Class II Deerfield Imaging, Inc.
Jun 26, 2019 SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), par... There was a higher than normal incidence rate of the blade not retracting when tightening. Class II MicroAire Surgical Instruments, LLC
Jun 25, 2019 MAGEC 1 System Safety Alert to all surgeons informing them of post-implantation fractures of an internal metalli... Class II NuVasive Specialized Orthopedics, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x110, Item Number 19670 - Product Usage:Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, 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.