Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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 5, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Atrium Firm PVC Thoracic Catheter 36FR Straight A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report14 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Florida, Iowa, Illinois, Indiana, Maryland, Michigan, Minnesota, New Jersey, Pennsylvania, Tennessee and Texas
- Medical device recall Atrium Oasis Dry Suction Water Seal Chest Drain Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the… Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportVirginiathe one state its words name PublishedDec 13, 2023ClassClass IIStatusOngoingWhereVirginia
- Medical device recall Atrium Oasis Dry Suction Water Seal Chest Drain Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the… Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportVirginiathe one state its words name PublishedDec 13, 2023ClassClass IIStatusOngoingWhereVirginia
- Medical device recall Remington MEDICAL Drainage Bag There is an error with the “Use by Date” and “Date of Manufacturer” on the box label. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereFlorida and Pennsylvania
- Medical device recall vyaire Flexible Patient Circuit, 3100A Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportFloridathe one state its words name PublishedDec 13, 2023ClassClass IIStatusCompletedWhereFlorida
- Medical device recall vyaire Flexible Patient Circuit, 3100A Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportFloridathe one state its words name PublishedDec 13, 2023ClassClass IIStatusCompletedWhereFlorida
- Medical device recall STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone… Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the… Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of… Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of… Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain Defect in the outer packaging of the Cranial Access Kits. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain Defect in the outer packaging of the Cranial Access Kits. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain Defect in the outer packaging of the Cranial Access Kits. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain Defect in the outer packaging of the Cranial Access Kits. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain Defect in the outer packaging of the Cranial Access Kits. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain Defect in the outer packaging of the Cranial Access Kits. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral… Defect in the outer packaging of the Cranial Access Kits. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Luminex VERIGENE BC-GP Utility Tray Potentially defective utility trays in the reagent kits. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oklahoma, Oregon, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall RANDOX Total Bilirubin. Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Georgia, North Carolina, Puerto Rico and Tennessee named
- Medical device recall Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or… Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography… Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and… Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Florida, North Carolina, New Jersey and New York named
- Medical device recall Stay Safe Cap Updating the labeling to include additional warnings and contraindications for potential side effects. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED Due to incorrect product/device within packaging. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may… Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury,… Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedDec 6, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall SENTIERO, mobile medical devices for hearing examinations Affected lots of product may experience technical distortions to a greater extent than expected. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereFlorida, Missouri, Ohio and Wisconsin
- Medical device recall SENTIERO Screening2, mobile medical devices for hearing examinations Affected lots of product may experience technical distortions to a greater extent than expected. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereFlorida, Missouri, Ohio and Wisconsin
- Medical device recall AuDX PRO, mobile medical devices for hearing examinations Affected lots of product may experience technical distortions to a greater extent than expected. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereFlorida, Missouri, Ohio and Wisconsin
- Medical device recall SENTIERO SCREENING, mobile medical devices for hearing examinations Affected lots of product may experience technical distortions to a greater extent than expected. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereFlorida, Missouri, Ohio and Wisconsin
- Medical device recall with Notch 22M/15F Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV… Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Da Vinci Single-Site Wristed Needle Driver There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report14 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Idaho, Illinois, Michigan, Mississippi, New Jersey, New York, Oregon, Puerto Rico, South Carolina, Tennessee and Texas
- Medical device recall Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090 Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of… Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Lugol s Iodine Solution 500ML Due to the incorrect packaging utilized with lot 3124, there’ s an improper seal between the cap and bottle. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereCalifornia, New Jersey and West Virginia
- Medical device recall Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5 Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report51 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report51 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall FloTrac Sensor Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report51 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall FloTrac Sensor with Vamp System Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report51 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall TruWave Pressure monitoring set Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report51 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall TruWave with Vamp System Pressure monitoring set Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report51 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereFlorida, Kentucky, Massachusetts, New Jersey, New York and Pennsylvania
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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