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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

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Clear
DateProductReasonClassFirm
Jun 13, 2018 O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in ... There is a potential for imaging artifact to mimic calcifications on patient's mammograms Class II Beekley Corporation
Jun 13, 2018 Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 7402121... The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Aust... Class II Smith & Nephew, Inc.
Jun 13, 2018 JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 7402... The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Aust... Class II Smith & Nephew, Inc.
Jun 13, 2018 JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 7402... The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Aust... Class II Smith & Nephew, Inc.
Jun 13, 2018 Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 500... An improper wiring connection on the chiller assembly may result in overheating of the connection... Class II Bard Medical Division
Jun 13, 2018 TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin f... There is a potential for imaging artifact to mimic calcifications on patient's mammograms Class II Beekley Corporation
Jun 13, 2018 S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in ... There is a potential for imaging artifact to mimic calcifications on patient's mammograms Class II Beekley Corporation
Jun 12, 2018 Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators... In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for th... Class I Philips Respironics, Inc.
Jun 12, 2018 Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep... Incorrect use-by date on the device registration/patient file labels. Class II Inspire Medical Systems Inc.
Jun 12, 2018 Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Us... The incorrect plastic was used to manufacture the handles of these shears, which causes the handl... Class II Teleflex Medical Europe Ltd
Jun 11, 2018 NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) ... There is a potential risk of electrical fire when fluid leaks into the power receptacle on the ba... Class II NxStage Medical, Inc.
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double S... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Allura Xper Product Usage: Vascular,cardiovascular and neurovascular im... The first time an operator selects a new procedure type during a single examination,the shutter p... Class II Philips Healthcare
Jun 11, 2018 Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, b... Device could not meet the requirements for systolic pressure Class II Withings Sas
Jun 11, 2018 MyLab Seven, Model 6400 The probe power monitoring settings have been found to be not appropriate under specific operati... Class II ESAOTE S.P.A.
Jun 11, 2018 MyLab Alpha, Model 7400 The probe power monitoring settings have been found to be not appropriate under specific operati... Class II ESAOTE S.P.A.
Jun 11, 2018 UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging a... The first time an operator selects a new procedure type during a single examination,the shutter p... Class II Philips Healthcare
Jun 11, 2018 MyLab Gamma, Model 7410 The probe power monitoring settings have been found to be not appropriate under specific operati... Class II ESAOTE S.P.A.
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Centron Product Usage: Vascular,cardiovascular and neurovascular imagin... The first time an operator selects a new procedure type during a single examination,the shutter p... Class II Philips Healthcare
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, ... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, ... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pedia... The product may be packaged with the incorrect length of feeding tube as labeled. Class II Canadian Hospital Specialties
Jun 11, 2018 Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. Class II Edwards Lifesciences, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single S... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 8, 2018 Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coatin... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This pro... The device is not suitable for the control of the Troponin T assay due to unacceptable variation ... Class II Randox Laboratories Ltd.
Jun 8, 2018 Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Produ... Class II Stryker Neurovascular
Jun 8, 2018 Zimmer Dermatone AN, Model No. 88710100 Devices may have a loose control bar, which could compromise the ability to control the thickness... Class II Zimmer Surgical Inc
Jun 8, 2018 MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is ... Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. Class II Bio-Rad Laboratories, Inc
Jun 8, 2018 Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coa... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Pro... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coat... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item... Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingl... Class II Zimmer Biomet, Inc.
Jun 8, 2018 PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18... Products do not meet a tensile strength specification Class II Ethicon, Inc.
Jun 8, 2018 MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASele... Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. Class II Bio-Rad Laboratories, Inc
Jun 8, 2018 Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Pr... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coatin... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip pros... Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingl... Class II Zimmer Biomet, Inc.
Jun 8, 2018 PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single... Products do not meet a tensile strength specification Class II Ethicon, Inc.
Jun 8, 2018 PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Ar... Products do not meet a tensile strength specification Class II Ethicon, Inc.
Jun 8, 2018 Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Prod... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 7, 2018 GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the foll... The latest on-site software version may not have been reinstalled at some sites after service act... Class II GE Medical Systems, LLC
Jun 7, 2018 GE Healthcare MRI Systems, Software Version 12.x, sold under the following pr... The latest on-site software version may not have been reinstalled at some sites after service act... Class II GE Medical Systems, LLC

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.