Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions… Predict+ is being recalled for lack of pre-market clearance/approval. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Operating table TruSystem 7000 U (MB) The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter Operating Table TruSystem 7000 The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter Operating Table TruSystem 7000 (MBW) The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter Operating Table TruSystem 7000 (dV) The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter Operating Table TruSystem 7000 V The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter Operating Table TruSystem 7000 (MBW) V The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter Operating Table TruSystem 7000 (dV) V The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter Operating Table TruSystem 7000 U14 (MBW) The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter Operating Table TruSystem 7000 U14 (MBW) V The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall AD-TECH Spencer Probe Depth Electrode Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 30, 2024ClassClass IIStatusCompletedWhereNationwide, and California and Ohio named
- Medical device recall AD-TECH Spencer Probe Depth Electrode Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 30, 2024ClassClass IIStatusCompletedWhereNationwide, and California and Ohio named
- Medical device recall AD-TECH Spencer Probe Depth Electrode Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 30, 2024ClassClass IIStatusCompletedWhereNationwide, and California and Ohio named
- Medical device recall A1CNow+ Multi-Test HbA1c System consists of The reason for this recall is PTS Diagnostics, Inc. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and… The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedOct 30, 2024ClassClass IIStatusCompletedWhereNationwide, and Alabama, California, Florida, Kentucky, Massachusetts, Maine, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah and West Virginia named
- Medical device recall EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to… Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, New Jersey, New York, Pennsylvania, Tennessee, Virginia and Wisconsin
- Medical device recall Boston Scientific myLUX Patient Application for an Apple Mobile device Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Kentucky, Massachusetts, Maryland, North Carolina, New Jersey, New York, Ohio, Puerto Rico, South Carolina, Utah, Virginia and Washington named
- Medical device recall Cook Medical Hemo-7 Hemospray Endoscopic Hemostat Specific lots of product have been manufactured with nonconforming raw materials. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GE Heathcare Giraffe OmniBed GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 23, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 23, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall GE Heathcare Giraffe OmniBed Carestation GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 23, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 23, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall KINOVA Jaco assistive robot Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair exhibiting… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 23, 2024ClassClass IStatusOngoingWhereNationwide, and California, Missouri, North Carolina and Ohio named
- Medical device recall EVIS EXERA III Video System Center Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Monarch Inflation Device 30 atm/bar Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF… Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque… Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Melrose Wakefield Hospital Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and… May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Blue Diamond Digital Inflation Device Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall basixTOUCH Inflation Device Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall DiamondTOUCH Digital Inflation Device Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall IntelliSystem Inflation Device Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall BlueFIRE Inflation Device Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall MONARCH Inflation Device Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Custom Inflation Kit Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall basixSKY Inflation Device Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall basixTOUCH Inflation Device Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall StabiliT TOUCH Syringe Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Leica Biosystems Cryostat As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leica Biosystems Cryostat As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leica Biosystems Cryostat As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leica Biosystems Cryostat As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leica Biosystems Cryostat As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leica Biosystems Cryostat As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cue Health COVID-19 Test Cartridge Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false… Class IIIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 23, 2024ClassClass IIIStatusOngoingWhereNo state named
- Medical device recall The Access TSH Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
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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