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 6, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall ‘n’-Hole Post which is a component of the Revolution External Fixation System The threads on posts stripping out when tensioned during application process. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, Connecticut, Ohio, Texas and Virginia named
- Medical device recall Philips Tempus LS-Manual Defibrillator Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing… Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Georgia, Illinois, Kansas, Nebraska, Texas, Utah and West Virginia named
- Medical device recall Icelock 125 Ratchet A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected,… Class IIFDA’s classJun 21, 2023in FDA’s Enforcement Report44 statesnamed in where it went PublishedJun 21, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014… Class IIIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 21, 2023ClassClass IIIStatusOngoingWhereNo state named
- Medical device recall Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F There is a potential that valve assemblies will not open. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F There is a potential that valve assemblies will not open. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F There is a potential that valve assemblies will not open. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F There is a potential that valve assemblies will not open. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aspira Pleural Drainage Catheter Insertion Tray 15.5F There is a potential that valve assemblies will not open. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aspira Pleural Drainage Catheter Insertion Tray 15.5F There is a potential that valve assemblies will not open. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aspira Pleural Drainage Catheter Insertion Tray 15.5F There is a potential that valve assemblies will not open. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aspira Pleural Drainage Catheter Insertion Tray 15.5F There is a potential that valve assemblies will not open. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aspira Valve Repair Kit There is a potential that valve assemblies will not open. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aspira Drainage Catheter Insertion Tray 15.5F There is a potential that valve assemblies will not open. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aspira Drainage Catheter Insertion Tray 15.5F There is a potential that valve assemblies will not open. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aspira Drainage Catheter Insertion Tray 15.5F There is a potential that valve assemblies will not open. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aspira Drainage Catheter Insertion Tray 15.5F There is a potential that valve assemblies will not open. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Exeter V40 Trial Head, 26mm, -3 The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall bellavista 1000 Ventilator, Catalogue Number 301.100.030 Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2023ClassClass IIStatusCompletedWhereNationwide
- Medical device recall bellavista 1000e Ventilator, Catalogue Number 301.100.130 Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2023ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Tearaway Introducer Kit Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges… Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Massachusetts, New Jersey, Nevada, New York, Ohio, Pennsylvania and Utah named
- Medical device recall Tearaway Introducer Set Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges… Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Massachusetts, New Jersey, Nevada, New York, Ohio, Pennsylvania and Utah named
- Medical device recall SteriPack Sterile Polyester Spun Swabs Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Driver Instrument, part of the Superion Indirect Decompression System Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver… Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Total Knee Pack Incorrect expiration date on product. Class IIIFDA’s classJun 21, 2023in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedJun 21, 2023ClassClass IIIStatusOngoingWhereMassachusetts
- Medical device recall StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation… During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 14, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6… There have been reports of skin burns to children wearing the device. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Trilogy Evo, Garbin Evo, and Aeris EVO Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Trilogy Evo O2 and LifeVent EVO2 Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Trilogy Evo O2 EV300 Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Trilogy Evo Universal Ventilator The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall StealthStation Cranial Software In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 14, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJun 14, 2023ClassClass IStatusOngoingWherePuerto Rico
- Medical device recall Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil. There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Iowa, Kansas, Louisiana, Michigan, New Jersey, New Mexico, New York, Oklahoma, Pennsylvania, Tennessee, Texas and Wisconsin named
- Medical device recall The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche… SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association… IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break… Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association… IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break… Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with… IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break… Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with… IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break… Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with… IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break… Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the… IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by… Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223 Faulty cartridges in the lot could result in false test results. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Maryland, Mississippi, New York, Oklahoma, Pennsylvania and Tennessee named
- Medical device recall AVNS ambIT System - PIB/PCA W 2.5in Cath Some of the ambIT kits were potentially distributed without an air in-line filter. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 14, 2023ClassClass IIStatusTerminatedWhereNationwide, and Oregon and Texas named
- Medical device recall AVNS ambIT System - PIB/PCA W 5in Cath Some of the ambIT kits were potentially distributed without an air in-line filter. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 14, 2023ClassClass IIStatusTerminatedWhereNationwide, and Oregon and Texas named
- Medical device recall SMMT ambIT Kit Basic Filter Luer Cass Some of the ambIT kits were potentially distributed without an air in-line filter. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 14, 2023ClassClass IIStatusTerminatedWhereNationwide, and Oregon and Texas named
- Medical device recall SMMT ambIT Reusable Program - Luer Cass Some of the ambIT kits were potentially distributed without an air in-line filter. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 14, 2023ClassClass IIStatusTerminatedWhereNationwide, and Oregon and Texas named
- Medical device recall ambIT Cassette Filter Male Luer Some of the ambIT kits were potentially distributed without an air in-line filter. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 14, 2023ClassClass IIStatusTerminatedWhereNationwide, and Oregon and Texas named
- Medical device recall The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main… Potential for the incorrect size stent-graft than the printed carton label. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, New York, Virginia and Washington named
- Medical device recall Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack Inadvertently released for distibution without sterility assurance. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJun 14, 2023ClassClass IIStatusOngoingWhereGeorgia
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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