Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, 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.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall Alinity m System There is a potential for abnormal (non-sigmoidal) amplification curves. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alinity m System There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alinity m System There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Alinity m System There is an issue with the installation of updated camera firmware on the system. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement Report16 statesnamed in where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Georgia, Illinois, Kentucky, Maryland, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Rhode Island, South Dakota, Texas and Wisconsin
- Medical device recall Instructions for Use for all There have been reports of stent migration. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Model B35200 - Percept PC BrainSense Implantable Neurostimulator During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall da Vinci SP Surgical systems with the following Issue was identified during internal engineering evaluation. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, Florida, Illinois, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 5, 2022ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test Devices are determined to be inconsistent with the firm’s Emergency Use Authorization (EUA). Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNew York
- Medical device recall RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD. There is an error in the new version of the package insert. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJan 5, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube… Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating… Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS PRG Progesterone bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS Clostridium Difficile GDH bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS DEX@, Dimer Exclusion II bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS B.R.A.H.M.S bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS Mumps IgG (MPG) bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS Measles IgG (MSG) bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS TOXO IgG Avidity (TXGA) bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS RUB IgG (RBG) bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS LH, REF 30406-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS FSH, REF 30407-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS Estradiol II bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS Lyme IgM II (LYM) bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS Lyme IgG II (LYM) bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS SARS-COV-2 IgM bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS SARS-COV-2 IgG bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of… ¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJan 5, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Massachusetts, Maryland, Mississippi, North Carolina, Nebraska, New Hampshire, Ohio, Virginia and Wisconsin named
- Medical device recall ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for… Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the… Class IIFDA’s classJan 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 5, 2022ClassClass IIStatusTerminatedWhereNationwide, and Iowa, Louisiana, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina and South Dakota named
- Medical device recall Karl Storz Udel Sterilization Tray Instructions for Use, Tray To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes… Class IIFDA’s classJan 5, 2022in FDA’s Enforcement Report51 statesnamed in where it went PublishedJan 5, 2022ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United… Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is… Class IIFDA’s classJan 5, 2022in FDA’s Enforcement Report47 statesnamed in where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C… Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is… Class IIFDA’s classJan 5, 2022in FDA’s Enforcement Report47 statesnamed in where it went PublishedJan 5, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
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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