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 Modular Head Component, Biomet Hip System Two lots of different sized modular heads potentially commingled. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Florida, Georgia, Indiana, Kentucky, Louisiana, Missouri, Mississippi, Ohio, Oklahoma, Texas and Virginia named
- Medical device recall Modular Head Component, Biomet Hip System Two lots of different sized modular heads potentially commingled. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Florida, Georgia, Indiana, Kentucky, Louisiana, Missouri, Mississippi, Ohio, Oklahoma, Texas and Virginia named
- Medical device recall WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED Incorrect tip was used during manufacturing of the Osher Thermodot Marker. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereFlorida, Kansas, Minnesota, New York and Ohio
- Medical device recall Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is… May produce erroneously low results from specific well sets. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Specimen Gate Screening Center Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Alere iScreen Dx Urine Drug Screen Card The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in… Class IIIFDA’s classMay 9, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedMay 9, 2018ClassClass IIIStatusTerminatedWhereArizona, Florida, Illinois, North Dakota, Nevada, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall PTS Panels¿ CHOL+GLU Test Strips (REF 1765) Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018) Class IIFDA’s classMay 9, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereFlorida, Illinois, Kentucky, Minnesota, New York, Ohio, Puerto Rico, Tennessee, Virginia and Washington
- Medical device recall BD MAX DNA MMK (SPC) For Laboratory Use The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Class IIIFDA’s classMay 9, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 9, 2018ClassClass IIIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York, Oregon, Pennsylvania, Virginia and Wisconsin
- Medical device recall BD MAX DNA MMK Lab Use The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Class IIIFDA’s classMay 9, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 9, 2018ClassClass IIIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York, Oregon, Pennsylvania, Virginia and Wisconsin
- Medical device recall Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) products may be missing a one-way valve on the fluid patient port. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the… There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Wisconsin named
- Medical device recall DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft Non-sterile product was packaged inside a case that was labeled as sterile. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length Products have been packaged with the wrong Trocar length type. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Indiana and New Jersey named
- Medical device recall MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for… Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNew York
- Medical device recall Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens. When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens. When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens. When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional… After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall StoneBreaker Pneumatic Lithotripter The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall StoneBreaker Exhaust Cap The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall StoneBreaker Exhaust Line The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall StoneBreaker Probe Cap The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall StoneBreaker Sterilization Cap The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall StoneBreaker C02 Cartridge The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall StoneBreaker Single Use Probe The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner. Error introduced into PET images acquired and reconstructed with VJ20A software. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 6376 M-1 Cot Fastener The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 6381 M-1 Cot Fastener The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall HYPOTHERMIA CAP Supportive in Cancer Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HYPOTHERMIA MITTS Supportive in Cancer Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HYPOTHERMIA SLIPPERS Supportive in Cancer Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy,… The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy,… The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF,… The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system,… The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging… The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system,… The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system,… The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas b 221<2>Roche OMNI S2 system The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cobas b 221<4>Roche OMNI S4 system The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas b 221<6>Roche OMNI S6 system The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas b 221 AutoQC Module Complete The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Miriam Capsule Endoscope System When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Missouri, North Carolina, New York, Ohio, Tennessee and Texas named
- Medical device recall Nanosil Spray Gel, “***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***”, Net A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cGMP) deficiencies including lack of data to support products… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereAlabama, Massachusetts and Mississippi
- Medical device recall Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for… Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Crimson Trace Corporation laser sights A previously “in specification” Finished Product with a Model 25-0657 diode had power output higher than 5 mW. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Triathlon Revision Knee Customers may receive the incorrect size implant from what is labeled on the box. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Kansas, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall The humeral stems trials are Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral… Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
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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