Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Brilliance iCT SP Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance Big Bore (Oncology) Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance Big Bore (Radiology) Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance 16 Slice (Air) Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance 64 Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IQon Spectral CT Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance 6 Slice (Air) Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo HX2 Temperature Management System Update to cooler-heater cleaning instructions. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature . Update to cooler-heater cleaning instructions. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns TCM II Update to cooler-heater cleaning instructions. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cocaine Metabolite MICRO-PLATE EIA The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control. Class IIIFDA’s classApr 25, 2018in FDA’s Enforcement ReportKansasthe one state its words name PublishedApr 25, 2018ClassClass IIIStatusTerminatedWhereKansas
- Medical device recall Product: Milford Smartbase Recalling firm was informed that as a result of combination of a weak spring and incorrect alignment of the locking pin for latching the leg positions, product… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 25, 2018ClassClass IIStatusOngoingWherePennsylvania
- Medical device recall Manometer, 550 ml three-Way Stopcock The integrity of the sterile packaging is potentially compromised. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP] The integrity of the sterile packaging is potentially compromised. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA] The integrity of the sterile packaging is potentially compromised. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6] The integrity of the sterile packaging is potentially compromised. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6] The integrity of the sterile packaging is potentially compromised. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Thoracentesis/ Paracentesis Kit 10/CS The integrity of the sterile packaging is potentially compromised. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE) Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Halyard Closed Suction System for Adults, Turbo-… Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Multiva systems, 1) Multiva 1.5T 8 R5 Potential risk for helium gas inside the MR examination room during a magnet quench Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intera 0.5T Standard Potential risk for helium gas inside the MR examination room during a magnet quench Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for use as a diagnostic… Potential risk for helium gas inside the MR examination room during a magnet quench Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera… Potential risk for helium gas inside the MR examination room during a magnet quench Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Panorama 1.0T Potential risk for helium gas inside the MR examination room during a magnet quench Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Achieva 1.5T: 1) Nova (Dual) Potential risk for helium gas inside the MR examination room during a magnet quench Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Conversion SmarthPath to dStream for 1.5T Potential risk for helium gas inside the MR examination room during a magnet quench Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic device Potential risk for helium gas inside the MR examination room during a magnet quench Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional… Potential risk for helium gas inside the MR examination room during a magnet quench Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional… Potential risk for helium gas inside the MR examination room during a magnet quench Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional… Potential risk for helium gas inside the MR examination room during a magnet quench Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Multiva systems Potential risk for helium gas inside the MR examination room during a magnet quench Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional… Potential risk for helium gas inside the MR examination room during a magnet quench Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stage-1 Tissue Punch, Disposable, 4.5mm The cutting edge of tissue punches may be potentially damaged with small dents and nicks. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System This device was mislabeled and is not the correct component for this patient. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607 Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275 Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood… Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, North Carolina, New York, Ohio and Virginia
- Medical device recall IntelliVue X3 Patient Monitor. The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator. A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 18, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of… Product has been found with a missing Washer, Retaining Ring, and/or Stop Screw. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Hawaii, Iowa, Illinois, Louisiana, Massachusetts, Minnesota, New Jersey, Ohio, Pennsylvania, Tennessee, Texas, Utah and Virginia named
- Medical device recall Progressa Bed - AC-powered adjustable hospital bed A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result… Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system… Class IIFDA’s classApr 18, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereCalifornia, Michigan, North Carolina, Puerto Rico, Texas and Washington
- Medical device recall Hematology Diluent M-53D used with BC-5390 Hematology Analyzer Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzer may cause the system… Class IIFDA’s classApr 18, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereCalifornia, Michigan, North Carolina, Puerto Rico, Texas and Washington
- Medical device recall VITROS Immunodiagnostic Products TSH Reagent Pack VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. Class IIIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 18, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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