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 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Contains a gel-like contaminant that may affect product performance. Class IIIFDA’s classAug 8, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedAug 8, 2018ClassClass IIIStatusTerminatedWhereArizona, California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas and Wisconsin
- Medical device recall Liquid Cardiac Control - Level 3 The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportWest Virginiathe one state its words name PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereWest Virginia
- Medical device recall Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr Product contains dry natural rubber latex. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 8, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Discovery IQ 2.0 20cm, 4 ring Some CT and CT/PET systems recently installed with a GE supplied A! Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Discovery MI Digital Ready DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring Some CT and CT/PET systems recently installed with a GE supplied A! Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Discovery RT labeled as: a Some CT and CT/PET systems recently installed with a GE supplied A! Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Revolution CT 160 1.5D STD WAUK Some CT and CT/PET systems recently installed with a GE supplied A! Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall CT Goldseal Optima CT 600 Some CT and CT/PET systems recently installed with a GE supplied A! Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Revolution EVO 3.6, labeled as a Some CT and CT/PET systems recently installed with a GE supplied A! Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Optima CT 520 Some CT and CT/PET systems recently installed with a GE supplied A! Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Optima CT 540 Some CT and CT/PET systems recently installed with a GE supplied A! Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall CT Goldseal BrightSpeed 16 PWR TIO 2 YR Some CT and CT/PET systems recently installed with a GE supplied A! Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall VIDAS LH, Reference Numbers 30406 and 30406-01 Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona and North Carolina named
- Medical device recall Final Pack, Esteem II, Sound Processor Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereFlorida and Oregon
- Medical device recall ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL… ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing… Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MAYFIELD INFINITY XR2 BASE UNIT There is a potential for the knob assembly in the swivel adapter to fracture/break during use. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall MAYFIELD Infinity XR2 Base Unit-Extended There is a potential for the knob assembly in the swivel adapter to fracture/break during use. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT There is a potential for the knob assembly in the swivel adapter to fracture/break during use. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT There is a potential for the knob assembly in the swivel adapter to fracture/break during use. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall EZ1 DSP Virus Kit Underfilled reagent well that could lead to incorrect results Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportMarylandthe one state its words name PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereMaryland
- Medical device recall power cord for: (a) AMIA Automated PD Cycler There were instances where the power cord socket detached from the back of the AMIA cycler when the power cord was unplugged from the socket. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use. Class IIIFDA’s classAug 8, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 8, 2018ClassClass IIIStatusTerminatedWhereFlorida, Kansas, Kentucky, Massachusetts, New Jersey and South Dakota
- Medical device recall MicroScan Pos Combo Panel Type 43 The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Iowa, Louisiana, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania and Texas
- Medical device recall Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM) A black, aluminum oxide coating may appear on the tray after cleaning. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Indiana, Michigan, Minnesota, Missouri, New Jersey, Nevada, New York, Ohio, Rhode Island, South Carolina, Tennessee, Texas, Utah and Washington
- Medical device recall Polysorb Braided Absorbable Suture 1 36” 90 cm Undyed GS-21, Product Number CL-955 Potential proplylene glycol contamination Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereCalifornia, New York and Texas
- Medical device recall Zimmer Dermatone AN Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Florida, Iowa, Illinois, Massachusetts, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Rhode Island, South Dakota and Texas
- Medical device recall Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including… The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic,… The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic,… The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereGeorgia, Rhode Island and Texas
- Medical device recall Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R Potential breakage of the endoscope s insertion tube bending section during surgical procedures Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Uretero-reno fiberscope URF-P6 Breakage of the endoscope’s insertion tube bending section during surgical procedures. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Uretero-reno fiberscope URF-P6RP6 Breakage of the endoscope’s insertion tube bending section during surgical procedures. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CORAIL Cementless Femoral Stem HA Coated Standard Size 11 Two lots of femoral stems were labeled as Size 11. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report14 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Georgia, Illinois, Louisiana, Maine, North Carolina, New Hampshire, New York, Oregon, Texas, Utah and Washington
- Medical device recall CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100)… Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brivo XR385, model 5215463, Digital Diagnostic Radiographic System The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam… Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report24 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, New Jersey, New Mexico, Oregon, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall ARTIS Pheno, Fluoroscopic X-Ray system During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety… Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Mississippi, New Jersey, New York, Ohio, Tennessee, Texas, Utah and Virginia
- Medical device recall AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118 Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut… Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereHawaii, Illinois, Michigan, North Carolina, New York, Virginia and Wisconsin
- Medical device recall Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118 Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut… Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereHawaii, Illinois, Michigan, North Carolina, New York, Virginia and Wisconsin
- Medical device recall MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T… There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of the patient… Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Illinois, Kansas, Michigan, Minnesota, New York, Ohio, Pennsylvania, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Invia Motion Negative Pressure Wound Therapy System Device may display a battery missing error. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania and Texas named
- Medical device recall Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm The product label has missing information, such as the lot number and expiration date, as well as other information. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, District of Columbia, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Vivo 65, Continuous Ventilator, Home Use Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool. Class IIIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 1, 2018ClassClass IIIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Michigan, South Carolina and Texas named
- Medical device recall Access Hi-Low Exam Tables One lot, the wire harness was over-crimped on some of the connectors that go to the two vertical side switches on the exam table. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereIllinois, Minnesota, Texas and Wisconsin
- Medical device recall PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm Products do not meet a tensile strength specification Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm Products do not meet a tensile strength specification Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm Products do not meet a tensile strength specification Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNo state 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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