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 PRIMO MRI DR SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall MIRRO MRI DR SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall MIRRO MRI DR SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall PRIMO MRI VR SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall MIRRO MRI VR SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall MIRRO MRI VR SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall COBALT DR MRI SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall COBALT DR MRI SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall COBALT VR MRI SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall Cobalt XT DR MRI SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall COBALT XT VR MRI SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall CROME VR MRI SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model… Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Missouri, North Carolina, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint… Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Louisiana, Michigan and North Carolina named
- Medical device recall 2nd Generation CentriMag Primary Console Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge… Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Kentucky, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Tennessee, Texas and Washington named
- Medical device recall NovaGuide 2 Traditional Ultrasound Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Kentucky, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Tennessee, Texas and Washington named
- Medical device recall Prelude Roadster Guide Sheath Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJul 3, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Stryker Hoffman LRF Wire Tensioner The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Kentucky, Massachusetts, Michigan, Nebraska, New Jersey, Ohio, Oregon and Texas named
- Medical device recall CDC, Influenza A/H5 Subtyping Kit The H5b component may fail to amplify, resulting in an inconclusive result. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue The affected products may have been packaged with a defect in the sterile barrier seal. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for… Product labels state the incorrect expiration dates that extends beyond their true expiration date Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedJul 3, 2024ClassClass IIStatusOngoingWhereMassachusetts
- Medical device recall Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for… Product labels state the incorrect expiration dates that extends beyond their true expiration date Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedJul 3, 2024ClassClass IIStatusOngoingWhereMassachusetts
- Medical device recall Ventilator HAMILTON-C6, PN: 160021 Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 26, 2024ClassClass IStatusOngoingWhereNationwide, and California, Florida, Georgia, Indiana, Kentucky, Michigan, Nevada, Oregon, Pennsylvania, South Carolina, Texas and Virginia named
- Medical device recall ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator’s Guide and Quick Reference… Operator’s Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation,… Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation… Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in… Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation,… Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation… Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue… Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become… Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and West Virginia named
- Medical device recall Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support… There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the… Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HRIS Storage & Sterilization Case and Tray The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead… Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gray Revision Instrument System Accessory Tray/Case The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead… Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Bard Medical SureStep Foley Tray System, 16 Fr. Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices. Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OPTETRAK Three Peg Patella Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall OPTETRAK One Peg Patella Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall OPTETRAK Inset Patella Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall OPTETRAK, Advanced Patella, 3 Peg Implant Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up The wrong configuration of the blade was in the package. Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up The wrong configuration of the blade was in the package. Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Thoratec HeartMate System Monitor System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 19, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Preview Strep A, Streptococcal A rapid test kits Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid… Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at… Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 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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