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 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP) Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 2, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 2, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP) Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 2, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 2, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP) Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 2, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 2, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP) Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 2, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 2, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Ivenix Infusion System (IIS), LVP Software The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall The device is a mobile x-ray system designed to work with Fujifilm’s GOS and CsI scintillator FDR D-EVO2… When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the… Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Silver-Plated Copper Sims Uterine Sound During the manufacturing process the devices were laser-marked with the incorrect part number. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stainless Steel Sims Uterine Sound During the manufacturing process the devices were laser-marked with the incorrect part number. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Prelude Sheath Introducer 7.5F 7F sheath introducers labeled as 7.5F Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Georgia, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, Nevada, Ohio, Oregon, Pennsylvania, Texas and Wisconsin named
- Medical device recall Custom Procedure Kit 7F sheath introducers labeled as 7.5F Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Georgia, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, Nevada, Ohio, Oregon, Pennsylvania, Texas and Wisconsin named
- Medical device recall BioPince Ultra Full Core Biopsy Instrument Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic… Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or… Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or… Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images… Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images… Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images… Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images… Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images… Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or… Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra… Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images,… Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images,… Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images,… Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BARD MAGNUM Disposable Core Tissue Biopsy Needle Due to possible packaging damage (indentations/cuts) cause by manufacturing process. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean… Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Connecticut, Georgia, Illinois, Kansas, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior… Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall prodisc C SK, Total cervical disc replacement, medical device During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall prodisc C SK, Total cervical disc replacement During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GE Healthcare Centricty PACS, V2, V3, V4, V6, V7 GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min,… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement Report42 statesnamed in where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min,… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement Report42 statesnamed in where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall ACUSON Maple 1.0 Diagnostic Ultrasound System If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min,… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement Report42 statesnamed in where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Karl Storz - Endoskope Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Karl Storz - Endoskope Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Karl Storz - Endoskope Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Karl Storz - Endoskope Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Karl Storz - Endoskope Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Karl Storz - Endoskope Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Karl Storz - Endoskope Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Karl Storz - Endoskope Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 PACEMAKER PACK, SLCV01J ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Endovascular AAA Pack, ESED52B ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Endovascular AAA Pack, ESED52B ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Arthroscopy Pack, MSKA45A ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Open Shoulder, LWOS39L ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Day Surgery General Pack, FHGE18T ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio 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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