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 7, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall These wipes are saturated with 0.65% bleach solution There is stability concern for products dated with a 24-month shelf life. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital… Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR)… Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereGeorgia
- Medical device recall GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus… GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 21, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 21, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator… GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 21, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 21, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 21, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 21, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Care Plus Hood Door FRU kit GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 21, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 21, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Lullaby Incubator GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 21, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 21, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Lullaby Incubator GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 21, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 21, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Impella catheters - Intravascular micro axial blood pumps that support a patient’s circulatory system. IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Samsung Digital Diagnostic Mobile X-ray System Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm. Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall AFT (Allograft Filler Tube) Straight Tube Filling process qualification did not demonstrate adequate process capability. Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereMinnesota
- Medical device recall AFT (Allograft Filler Tube) Diverted Tube Filling process qualification did not demonstrate adequate process capability. Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereMinnesota
- Medical device recall Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing Accessory sets contain a syringes not yet qualified for the accessory’s intended purpose; due to design changes to the syringe barrels and a polypropylene… Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement Report10 statesnamed in where it went PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereCalifornia, Florida, Massachusetts, Maryland, North Dakota, Nebraska, New Jersey, Ohio, Texas and Washington
- Medical device recall Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear… Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury… Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be… Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding,… Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan… Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan… Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella catheters - Intravascular micro axial blood pumps that support a patient’s circulatory system. New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may… Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet) The negative control was contaminated with one of the positive control pathogens (Norovirus). Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the… The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BEQ-HLS 7050 USA, HLS Set Advanced 7.0 The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 3:1 Dermacarrier Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, Montana, North Carolina, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall MobileDiagnost wDR While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the… Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Neurovascular, Trevo Pro 18 Microcatheter The microcatheter IFU contains an intended use that has not been evaluated by the FDA. Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Georgia, Hawaii, Illinois, Michigan, North Carolina, New Hampshire, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall Stryker Neurovascular, Trevo Trak 21 Microcatheter The microcatheter IFU contains an intended use that has not been evaluated by the FDA. Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Georgia, Hawaii, Illinois, Michigan, North Carolina, New Hampshire, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used… One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Louisiana, New York and Tennessee named
- Medical device recall CombiDiagnost R90 1.0 While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient’s radiography… Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Maine, Michigan, Minnesota, North Carolina, New Jersey, New York, Texas, Virginia and Washington named
- Medical device recall CombiDiagnost R90 1.1 While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient’s radiography… Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Maine, Michigan, Minnesota, North Carolina, New Jersey, New York, Texas, Virginia and Washington named
- Medical device recall global Medium The firm has become aware of a sudden increase in complaints for three associated lots. Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and West Virginia named
- Medical device recall BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD… Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10,… Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in… Class IIFDA’s classFeb 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 21, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Illinois, Michigan, North Carolina and Texas named
- Medical device recall 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF… Due to software and controller systems that results in unexpected pump start or pump stop. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Senographe Pristina X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BrightView, gamma camera system Detector may unexpectedly fall due to a component failure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IStatusOngoingWhereNationwide
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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