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 BrightView X, gamma camera for SPECT 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
- Medical device recall BrightView XCT, gamma camera for SPECT 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
- Medical device recall Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation… Magnetic materials were used for the wheels of trolley. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida and New York named
- Medical device recall Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient… Magnetic materials were used for the wheels of trolley. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida and New York named
- Medical device recall Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient… Magnetic materials were used for the wheels of trolley. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida and New York named
- Medical device recall FLEXSelect 5/16” Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Missouri, New Jersey, Texas, Utah and West Virginia named
- Medical device recall BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Maryland, Missouri, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas, Utah and Virginia named
- Medical device recall BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Maryland, Missouri, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas, Utah and Virginia named
- Medical device recall Barco MDSC-8527 NXF Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dual Articulating Headrest, Pad Ret P/N P141210805 Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Minnesota, Mississippi, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Dual Articulating Headrest, Velcro P/N P141210813 Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Minnesota, Mississippi, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Box as labeled: Regard, Carter-Thomason CloseSure System XL Incorrect component descriptions within the “Contents” section on the Tyvek lid for individual kit trays. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Missouri named
- Medical device recall AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic… Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach,… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Illinois and Texas named
- Medical device recall Flow-i C20 Anesthesia System Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia named
- Medical device recall Flow-i C30 Anesthesia System Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia named
- Medical device recall Flow-i C40 Anesthesia System Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia named
- Medical device recall Flow-c Anesthesia System Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia named
- Medical device recall Flow-e Anesthesia System Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia named
- Medical device recall RX Series Copper (Cu) Assay Ref Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Oklahoma and South Carolina named
- Medical device recall FilmArray Pneumonia Panel Plus (Pneumoplus) Their is a potential for false positive results when using Pneumonia panel. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall FilmArray Pneumonia Panel (Pneumo) Their is a potential for false positive results when using Pneumonia panel. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of… Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of… Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices… Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sperm separation media are used to separate motile sperm from other constituents of semen. The lower layer component of a sperm separation Kit does not match the certificate of analysis. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement Report21 statesnamed in where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereCalifornia, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Michigan, Minnesota, North Carolina, New Jersey, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Washington, Wisconsin and West Virginia
- Medical device recall HRIS ACET CUP CUT TIP 26X140 Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HRIS ACET CUP CUT TIP 32X140 Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to… The expiration date is missing from the primary (inner) packaging. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Guardian 4 Glucose Sensor Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 ¿m). Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Article No. NA6050411, Valiant PhD No. 1 Econo Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Indiana and Tennessee named
- Medical device recall ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023 The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, District of Columbia, Illinois, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall Water Filter MAJ-2318 Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045 Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereLouisiana, Maryland and Utah
- Medical device recall Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Ampicillin - 10 ¿g There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Augmentin - 3¿g There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Azithromycin -15 ¿g There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 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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