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.

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DateProductReasonClassFirm
Mar 23, 2018 Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article N... A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 23, 2018 Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Numbe... A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 23, 2018 Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Num... Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fib... Class II Medtronic Navigation, Inc.
Mar 23, 2018 The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intend... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the V... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099 A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 22, 2018 GE LOGIQ 9 ultrasound system Product Usage: The device is intended for ... The system side of the power cord may break and expose the electrical conductors leading to the r... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 22, 2018 Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intende... Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requi... Class II Cook Inc.
Mar 22, 2018 GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound s... The system side of the power cord may break and expose the electrical conductors leading to the r... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 22, 2018 BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 5038... BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... Class I Becton Dickinson & Company
Mar 22, 2018 GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is ... The system side of the power cord may break and expose the electrical conductors leading to the r... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 22, 2018 GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ... The system side of the power cord may break and expose the electrical conductors leading to the r... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 22, 2018 Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used... The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and ... Class II Volcano Corporation
Mar 22, 2018 GE Vivid E95 ultrasound system Product The device is intended for use by a... The system side of the power cord may break and expose the electrical conductors leading to the r... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 22, 2018 BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551) BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... Class I Becton Dickinson & Company
Mar 22, 2018 GE LOGIQ E9 ultrasound system Product Usage: The device is intended for u... The system side of the power cord may break and expose the electrical conductors leading to the r... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 22, 2018 BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 503829036... BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... Class I Becton Dickinson & Company
Mar 22, 2018 BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UD... BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... Class I Becton Dickinson & Company
Mar 22, 2018 GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultras... The system side of the power cord may break and expose the electrical conductors leading to the r... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 22, 2018 GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose... The system side of the power cord may break and expose the electrical conductors leading to the r... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 22, 2018 Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intend... Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requi... Class II Cook Inc.
Mar 21, 2018 Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic D... The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class II Madison Polymeric Engineering
Mar 21, 2018 Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205 The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2018 First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endo... The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class II Madison Polymeric Engineering
Mar 21, 2018 Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971 The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2018 First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Cle... The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class II Madison Polymeric Engineering
Mar 21, 2018 Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586 The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with... Class II Siemens Healthcare Diagnostics, Inc.
Mar 21, 2018 First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Cle... The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class II Madison Polymeric Engineering
Mar 21, 2018 Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flex... The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class II Madison Polymeric Engineering
Mar 21, 2018 First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Cle... The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class II Madison Polymeric Engineering
Mar 21, 2018 Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Pro... Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iod... Class II Bard Medical Division
Mar 20, 2018 BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company
Mar 20, 2018 First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/ca... Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) ... Class II Certified Safety Mfg Inc
Mar 20, 2018 BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ ... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company
Mar 20, 2018 Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Ext... There is an error in the caddy artwork that misidentifies a specific plate and screw. Class II Epic Extremity, LLC
Mar 20, 2018 Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.... There is an error in the caddy artwork that misidentifies a specific plate and screw. Class II Epic Extremity, LLC
Mar 20, 2018 BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 3... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company
Mar 19, 2018 Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extr... There is a potential for the connection screw of the stem extractor to break. Class II Synthes, Inc.
Mar 19, 2018 HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. Fo... Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated fol... Class II Hycor Biomedical Inc
Mar 19, 2018 Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVI... Teleflex Medical is recalling the affected product because there may be missing or incomplete inf... Class II Teleflex Medical Europe Ltd
Mar 16, 2018 ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic devi... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, ... Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone de... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 16, 2018 T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. ... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/P... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX... Update to cooler-heater cleaning instructions. Class II Terumo Cardiovascular Systems Corporation
Mar 16, 2018 Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling ... Update to cooler-heater cleaning instructions. Class II Terumo Cardiovascular Systems Corporation
Mar 16, 2018 Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model... Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone de... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 16, 2018 Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use ... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 78148... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation

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.