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 Zenostar MT Color B2 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 B3 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 B4 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 C1 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 C2 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 C3 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 C4 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 D2 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 D3 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 D4 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 Impulse orange, 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 RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning… RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high… Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mobile Column TruSystem 7500, Material Number 1717023 Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Georgia, Illinois, North Carolina, Oregon, South Carolina, Virginia, Wisconsin and Wyoming
- Medical device recall Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from… Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Georgia, Illinois, North Carolina, Oregon, South Carolina, Virginia, Wisconsin and Wyoming
- Medical device recall Floor Mounting Column TS 7500 U, Material Number 1730732 Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Georgia, Illinois, North Carolina, Oregon, South Carolina, Virginia, Wisconsin and Wyoming
- Medical device recall Operating Table TruSystem 7000 U, Material Number 1604788 Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Georgia, Illinois, North Carolina, Oregon, South Carolina, Virginia, Wisconsin and Wyoming
- Medical device recall ROI-A Anterior Delivery Device The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereArkansas, Florida, Georgia, Kentucky, North Carolina, Oregon and Pennsylvania
- Medical device recall Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner. It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement Report35 statesnamed in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Toshiba America Medical Systems, Inc It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement Report35 statesnamed in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Toshiba America Medical Systems, Inc It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement Report35 statesnamed in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Toshiba America Medical Systems, Inc It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement Report35 statesnamed in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall IgE Calibrator Series According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum… Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is… Class IIFDA’s classOct 12, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereMississippi and Tennessee
- Medical device recall TriFoillmaging Triumph/Triumph II Research CT scanners. The Firm has determined that several Triumph/Triumph II Research CT scanners produced by Northridge Trimodality Imaging, inc dba TriFoillmaging (or by Gamma… Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Kansas named
- Medical device recall CUSA Dissectron Fingertip Laparoscopic Cannula During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Kansas named
- Medical device recall Integral Lumbar Drainage Set During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Kansas named
- Medical device recall Integra Drainage Accessory Kits During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Kansas named
- Medical device recall Integra Ventricular Catheter Accessory Kit During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Kansas named
- Medical device recall Integra Lumbar Drainage Set During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Kansas named
- Medical device recall Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing… Arrow is recalling due to incorrect labeling of products. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161 Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge Class IIIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469 Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge Class IIIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall CT3Plus (a.k.a FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised… Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and… FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised… Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ReNew (a.k.a FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised… Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE Blue Impervious Gown with thumbhooks, X-large. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Arthrex Suture Washer The device was assembled incorrectly. Class IIIFDA’s classOct 12, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 12, 2016ClassClass IIIStatusTerminatedWhereCalifornia, Colorado, Florida, Idaho, Kentucky, Massachusetts, Minnesota, New York and Oregon
- Medical device recall Light Adaptor for Small Battery Drive and Small Battery Drive II. There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Adaptor for Small Battery Drive and Small Battery Drive II There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear… Software patch installation to address several safety issues. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray… Software patch installation to address several safety issues. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose… Software patch installation to address several safety issues. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alaris Syringe Module A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning… Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters Product gives incorrect low blood glucose levels. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedOct 5, 2016ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters Product gives incorrect low blood glucose levels. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedOct 5, 2016ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters Product gives incorrect low blood glucose levels. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedOct 5, 2016ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia 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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