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 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210 Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 27, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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 named
- Medical device recall 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240 Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 27, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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 named
- Medical device recall Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020,… Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 27, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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 named
- Medical device recall Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005 Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 27, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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 named
- Medical device recall Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722,… Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 27, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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 named
- Medical device recall AirFit N10 Nasal Masks and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 27, 2023ClassClass IStatusOngoingWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall AirFit F20 Full Face Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 27, 2023ClassClass IStatusOngoingWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall AirTouch F20 Full Face Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 27, 2023ClassClass IStatusOngoingWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall AirFit N20 Nasal Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 27, 2023ClassClass IStatusOngoingWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall AirTouch N20 Nasal Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 27, 2023ClassClass IStatusOngoingWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall AirFit F30 Full Face Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 27, 2023ClassClass IStatusOngoingWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall AirFit F30i Full Face Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 27, 2023ClassClass IStatusOngoingWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 27, 2023ClassClass IStatusOngoingWhereCalifornia, Colorado, New Jersey, Utah and Wisconsin
- Medical device recall Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10… Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment… Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223… Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment… Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system… Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette Cassette did not meet an 1n-process flow criterion. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereArizona and Florida
- Medical device recall CardioQuip Modular Cooler-Heater There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereCalifornia, Nebraska, Ohio, Pennsylvania, Texas and Washington
- Medical device recall CardioQuip Modular Cooler-Heater There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereCalifornia, Nebraska, Ohio, Pennsylvania, Texas and Washington
- Medical device recall AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle… Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report13 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereAlabama, Florida, Georgia, Kansas, Louisiana, Maryland, Michigan, North Carolina, New Jersey, New York, Texas, Wisconsin and West Virginia
- Medical device recall Biolox Ceramic Option Head Zimmer 12/14 40mm -3 One product complaint was received reporting that there was an incorrect adapter in the packaging. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereAlabama, California, Maryland, Michigan, North Carolina, Ohio, Oklahoma, Tennessee and Texas
- Medical device recall Biolox Ceramic Option Head Zimmer 12/14 40mm +0 One product complaint was received reporting that there was an incorrect adapter in the packaging. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereAlabama, California, Maryland, Michigan, North Carolina, Ohio, Oklahoma, Tennessee and Texas
- Medical device recall Injection Needle The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if… Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereAlaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Injection Needle, 3 Fr. The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if… Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereAlaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Injection Needle, LUER-lock,0.8mm The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if… Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereAlaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Injection Needle, single cvd. 70 degrees The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if… Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereAlaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Injection Needle, curved 23 cm The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if… Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereAlaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall The device is a whole-body CT x-ray system Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect… Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report25 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusCompletedWhereAlabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Michigan, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee and Texas
- Medical device recall AcuMatch Hip System Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereArkansas, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Exactech Alteon Hip XLE Liner Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereArkansas, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Exactech Equinoxe Reverse Shoulder System Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereArkansas, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Exactech Equinoxe Shoulder System Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereArkansas, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Exactech Novation Hip System Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereArkansas, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Exactech Optetrak Knee System Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereArkansas, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Exactech Optetrak Logic Knee System Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereArkansas, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Exactech Optetrak Logic PS Knee System Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereArkansas, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Exactech Truliant Knee System Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereArkansas, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Exactech Truliant, Activit-E Knee Insert Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereArkansas, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Exactech Vantage Ankle System Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereArkansas, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Exactech Vantage Mobile Bearing Tibial Inserts Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereArkansas, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Acrobat-i Vacuum Positioner System The Positioner Arm may not tighten or lock during normal use. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump… CARDIOHELP-i System was not properly tested to measure leakage current Class IIIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 27, 2023ClassClass IIIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA),… Siemens Healthcare Diagnostics Inc. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M The organization completed a product improvement process to the conjugate found within the certain ELISA kits. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereCalifornia, Massachusetts, Michigan, New Jersey, New York, Tennessee and Utah
- Medical device recall ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G The organization completed a product improvement process to the conjugate found within the certain ELISA kits. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereCalifornia, Massachusetts, Michigan, New Jersey, New York, Tennessee and Utah
- Medical device recall Abbott CELL-DYN Ruby The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2023ClassClass 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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