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 7, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall RayStation 7.0.0.19 Potential for reported SSD to be too high. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RayStation 8.0.0.61, 8.0.1.10 Potential for reported SSD to be too high. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5 Potential for reported SSD to be too high. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RayStation 9.0.0.113 and 9.0.1.142 Potential for reported SSD to be too high. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RayStation 9.1.0.933 and 9.2.0.483 Potential for reported SSD to be too high. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10 Potential for reported SSD to be too high. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RayStation 10.1.0.613 and 10.1.1.54 Potential for reported SSD to be too high. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15 Potential for reported SSD to be too high. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119 Potential for reported SSD to be too high. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89 Potential for reported SSD to be too high. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RayStation 14.0.0.3338 Potential for reported SSD to be too high. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RayStation 15.0.0.430 Potential for reported SSD to be too high. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall INNOMED CUP REMOVAL STARTER INSTRUMENT 54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement Report11 statesnamed in where it went PublishedMay 8, 2024ClassClass IIStatusCompletedWhereCalifornia, Florida, Georgia, Minnesota, North Carolina, New York, Pennsylvania, South Dakota, Texas, Utah and Virginia
- Medical device recall Battery Mobile X-ray Unit EASY MOVING Potential interference with the anti-fall system. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Illinois and New Jersey named
- Medical device recall Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to… Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall The Oncology Essentials Package of the Spectral CT imaging system. Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent… Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Hawaii, Minnesota, Vermont and West Virginia named
- Medical device recall Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an… Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334 Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 1, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 1, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall ACUSON Juniper Diagnostic Ultrasound System On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region… Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall ACUSON Redwood 1.0 Diagnostic Ultrasound System On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region… Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall ACUSON Maple Diagnostic Ultrasound System On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region… Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Alinity m System The Alinity m System camera detects whether tubes are “capped.” If the camera detects a cap and the retention bar is not present on the sample rack, the system… Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions. There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance. Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Kansas, Louisiana, Michigan, Texas and Virginia named
- Medical device recall Redux Electrolyte Creme, Product Ref. 66-04 Product demonstrates low viscosity. Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New York, Ohio, Pennsylvania, South Carolina and Texas named
- Medical device recall Mariner RDX Polyaxial Head Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface. Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Indiana, Michigan and Virginia named
- Medical device recall Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process. Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-) Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad… Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Route 92 Medical Full Length 070 Access System Their is the potential for distal tip separation at the proximal marker band of the delivery catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 1, 2024in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 1, 2024ClassClass IStatusOngoingWhereAlabama, Arizona, California, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and West Virginia
- Medical device recall Route 92 Medical, Full Length 070 Reperfusion System Their is the potential for distal tip separation at the proximal marker band of the delivery catheters FDA Class I, its most serious class Class IFDA’s class (needs attention)May 1, 2024in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 1, 2024ClassClass IStatusOngoingWhereAlabama, Arizona, California, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and West Virginia
- Medical device recall Route 92 Medical, 070 Access System Their is the potential for distal tip separation at the proximal marker band of the delivery catheters FDA Class I, its most serious class Class IFDA’s class (needs attention)May 1, 2024in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 1, 2024ClassClass IStatusOngoingWhereAlabama, Arizona, California, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and West Virginia
- Medical device recall Route 92 Medical, Tenzing 7 Delivery Catheter Their is the potential for distal tip separation at the proximal marker band of the delivery catheters FDA Class I, its most serious class Class IFDA’s class (needs attention)May 1, 2024in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 1, 2024ClassClass IStatusOngoingWhereAlabama, Arizona, California, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and West Virginia
- Medical device recall Route 92 Medical 070 Reperfusion System Their is the potential for distal tip separation at the proximal marker band of the delivery catheters FDA Class I, its most serious class Class IFDA’s class (needs attention)May 1, 2024in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 1, 2024ClassClass IStatusOngoingWhereAlabama, Arizona, California, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and West Virginia
- Medical device recall LightStrike Blackout Curtains Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to a bystander standing in the same room, but on the other side… Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nevada, Ohio, Oklahoma, Oregon, Tennessee, Utah, Washington, West Virginia and Wyoming named
- Medical device recall Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established… Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered… Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established… Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered… Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 20” Lead Wires, Replacement Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered… Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 48” Lead Wires, Replacement Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered… Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mariner RDX MIS Polyaxial Head Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking… Class IIFDA’s classMay 1, 2024in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida and Texas
- Medical device recall TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell Class IIFDA’s classMay 1, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2024ClassClass IIStatusOngoingWhereNationwide
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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