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 5, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT),… Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement Report13 statesnamed in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereAlabama, California, Colorado, Florida, Hawaii, Indiana, Kentucky, Nebraska, New York, Pennsylvania, South Carolina, Tennessee and Wisconsin
- Medical device recall Discovery MR750w 3.0T, whole body magnetic resonance scanner Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGNA Architect, Nuclear Magnetic Resonance Imaging System Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR,… Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads… Due to pin coming off of handles. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereConnecticut, Georgia, Minnesota, Montana and Texas
- Medical device recall Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereFlorida and New York
- Medical device recall Brand Name: Z-800 Infusion System Product Name: Z-800WF For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024. Class IIIFDA’s classDec 4, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 4, 2024ClassClass IIIStatusOngoingWhereAlabama, Florida, Louisiana, Michigan, Nebraska, New Jersey, Ohio and Texas
- Medical device recall 4.5 x 180 mm Due to holes detected in the inner barrier system that may compromise the sterility of the affected products. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Iowa, Indiana, Kansas, Massachusetts, Missouri, Montana, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall AMS Artificial Urinary Sphincter Control Pump Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, New York, Oregon, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, New York, Oregon, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall (1) Medline Open Heart CDS Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Georgia, Massachusetts, New Jersey and Pennsylvania named
- Medical device recall (1) Medline Pacer Implant Pack Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Georgia, Massachusetts, New Jersey and Pennsylvania named
- Medical device recall Medline Shoulder Repair Pack-LF Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Georgia, Massachusetts, New Jersey and Pennsylvania named
- Medical device recall VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP)… May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range)… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Florida, Idaho, Illinois, Kansas, Minnesota, Montana, New York, Pennsylvania and Utah named
- Medical device recall Achieva TX Interventional Coil 3.0T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall dS Breast 16ch 1.5T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall dS Breast 16ch 3.0T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall dS Breast 7ch 1.5T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall dS Breast 7ch 3.0T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mammotrak Diagnostic Coil 1.5T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mammotrak Interventional Coil 1.5T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mammotrak Diagnostic Coil 3.0T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mammotrak Interventional Coil 3.0T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SENSE Breast Coil Potential safety issue where a patient may be harmed while preparing for or during a scan. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SENSE Breast Coil 3.0T 7ch Potential safety issue where a patient may be harmed while preparing for or during a scan. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ST SENSE Breast Coil Potential safety issue where a patient may be harmed while preparing for or during a scan. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ST SENSE Breast Dx Coil Potential safety issue where a patient may be harmed while preparing for or during a scan. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Offset Cup Impactor - 3/8-16 interface Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Tennessee named
- Medical device recall GE Proteus XR/A radiographic system Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Merlin@home Transmitter Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior… Class IIIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedDec 4, 2024ClassClass IIIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Merlin@home with the MerlinOnDemand capability Transmitter Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior… Class IIIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedDec 4, 2024ClassClass IIIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, New Jersey, Nevada, New York, Ohio, Oklahoma, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL There have been cases of failure of the main board due to condensation water occurring in the gap between thermal insulation material on the underside of the… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Delaware and Pennsylvania named
- Medical device recall Tempus LS-Manual Defibrillator Due to incorrect labels applied to devices during servicing. Class IIIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 4, 2024ClassClass IIIStatusOngoingWhereNationwide, and Alabama, California, Florida, Missouri, New York, Ohio, Texas and Virginia named
- Medical device recall ENDO KIT, Medline Kit Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and New York named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state 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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