Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1,… GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0,… GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA MR380, with affected software versions: SV25.5, SV25.6 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA MR355, with affected software versions: SV25.5, SV25.6 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA MR360, with affected software versions: SV25.5, SV25.6 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Prime, with affected software versions: MR30.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Victor, with affected software versions: MR30.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA UHP, with affected software versions: RX28.0, MR30.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Discovery MR950, with affected software versions: 7T23.0 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BD PYXIS MEDBANK MINI CR-2HH-1FH-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK MINI CR-4HH-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-12HH-1FH Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-14HH-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-2HH-6FH Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-2HH-6FM Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Soltive Premium SuperPulsed Laser System Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soltive Pro SuperPulsed Laser System Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soltive SuperPulsed Laser System Wireless Footswitch Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TruDi NAV Suction, 0 Degrees Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement Report35 statesnamed in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont and Wisconsin
- Medical device recall IntelliVue Patient Monitor MX400 with L.x and M.x Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX450 with L.x and M.x Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX500 with L.x and M.x Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX550 with L.x and M.x Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter PST 500 U, Precision Surgical Table Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm Devices were labeled with an expiration date of four years and ten days rather than the validated two years. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Illinois, North Carolina, Ohio, Oklahoma and Washington named
- Medical device recall BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedAug 14, 2024ClassClass 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, 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 Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall American Contract Systems Hand Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Kansas, Maine, Minnesota, Missouri, Nebraska and South Dakota named
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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