Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ,… The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in… The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Blood Pressure Monitor UA-767PBT-Ci for small cuff A&D may have shipped blood pressure monitors that were not labeled for use with small cuff. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereMassachusetts, New York, Texas and Virginia
- Medical device recall TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall The Introes Pocket Bougie is an endotracheal tube introducer The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report14 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereArizona, Connecticut, Illinois, Indiana, Massachusetts, Missouri, North Carolina, Nebraska, New York, Ohio, Oregon, Pennsylvania, Utah and Wisconsin
- Medical device recall BioSentry Tract Sealant System Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report20 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Massachusetts, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Vermont and Washington
- Medical device recall V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and… Potential risk associated with corrosion demonstrated on the distraction screw surface. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Navigation O-arm O2 Surgical Imaging System Product O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Michigan, Missouri, Nebraska, Ohio and Washington named
- Medical device recall OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm… GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit… Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Kansas, Mississippi, New Jersey, Nevada, New York, Pennsylvania, Texas, Utah and West Virginia named
- Medical device recall ADVIA Centaur XPT Immunoassay System The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set… Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereMaryland, Minnesota and Mississippi
- Medical device recall Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging… Image data for a patients image may not be correct Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula Potential lack of assurance of sterility Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereIndiana and Tennessee
- Medical device recall Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport Potential lack of assurance of sterility Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereIndiana and Tennessee
- Medical device recall Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for… When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician’s Intent Rx Dose and/or the number of fractions, and then… Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report11 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Kentucky, Maryland, Missouri, Montana, North Carolina, New Jersey, Pennsylvania, Washington and Wisconsin
- Medical device recall Varian Head Frame Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head… Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as… One mislabeled dose of TheraSphere¿ Y-90 Glass Microspheres, which was shipped to Hong Kong (total radioactivity incorrect). Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Washington and Wisconsin
- Medical device recall Radiation Therapy Treatment Planning System For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, Montana, North Carolina, New York, Ohio, Texas and Washington
- Medical device recall Zero-Gravity Radiation Protection System Radiology Personnel protective shield. Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to… Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material… Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for… Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens… Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for… Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical… Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into… Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Kansas, Michigan, Missouri, New Jersey, Ohio, South Dakota, Texas, Utah and Washington named
- Medical device recall Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical… Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into… Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Kansas, Michigan, Missouri, New Jersey, Ohio, South Dakota, Texas, Utah and Washington named
- Medical device recall CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Hawaii, Illinois, Indiana, Kansas, Louisiana, Massachusetts, North Carolina, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended… Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when… Class IIIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Merit Inflation Syringe Kit Merit Medical Systems, Inc. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Vanguard 360 Revision Knee System Knee prostheses The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger… Class IIFDA’s classOct 12, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Kentucky, Minnesota, Oregon, Pennsylvania, Texas, Utah and Virginia
- Medical device recall 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for… Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Thermo Scientific QMS Everolimus Assay A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Iowa, Illinois, Kentucky, Mississippi, North Carolina, New York, Ohio and Texas named
- Medical device recall Brilliance 64 CT The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ingenuity Core The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ingenuity Core 128 The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ingenuity CT The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used… Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in hospitals,… Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical… Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Panoramic X-ray Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be… Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Zenostar MT Color Impulse blue, Art The primary packaging of these products may show leaks in individual cases. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Zenostar MT Color Impulse brown, art The primary packaging of these products may show leaks in individual cases. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Zenostar MT Color Impulse grey, art The primary packaging of these products may show leaks in individual cases. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Zenostar MT Color Impulse violet, art The primary packaging of these products may show leaks in individual cases. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Zenostar MT Color A1 60ml, art The primary packaging of these products may show leaks in individual cases. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Zenostar MT Color A2 60ml, art The primary packaging of these products may show leaks in individual cases. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Zenostar MT Color A3 60ml, art The primary packaging of these products may show leaks in individual cases. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Zenostar MT Color A3.5 60ml, art The primary packaging of these products may show leaks in individual cases. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Zenostar MT Color A4 60ml, art The primary packaging of these products may show leaks in individual cases. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Zenostar MT Color B1 60ml, art The primary packaging of these products may show leaks in individual cases. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin 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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