Medical devices
Shortlist up to four to read them side by side.
2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, 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.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support. Ventilator’s Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall VOCSN+Pro (Japan) Ventilator’s Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support. Ventilator’s Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall VC+Pro (Japan) Ventilator’s Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support. Ventilator’s Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall VOCSN (Japan) Ventilator’s Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support. Ventilator’s Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A;… Ventilator’s Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support. Ventilator’s Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support. Ventilator’s Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall V+ Pro Emergency Ventilator’s Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support. Ventilator’s Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Philips Lumify Diagnostic Ultrasound System Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 28, 2026ClassClass IStatusOngoingWhereNationwide, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Amplatzer Amulet Left Atrial Appendage Occluder Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI). Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Think Surgical Square Driver Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Delaware and New York named
- Medical device recall B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP Potential for leakage and backflow at the Safsite valve. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Indiana, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Texas and Washington named
- Medical device recall Medtronic NDI Passive Spheres Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement Report52 statesnamed in where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Medtronic NDI Passive Spheres Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement Report52 statesnamed in where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Medtronic NDI Passive Spheres Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement Report52 statesnamed in where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Medtronic Biopsy Needle Kit Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement Report52 statesnamed in where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall PNE Lead Implant Kit Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Philips Smart-hopping 2.0 AP 1.4 GHz Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+)… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, Illinois, Missouri, Nebraska, New York, Ohio, Pennsylvania and Virginia named
- Medical device recall ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima… Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima… Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareLink Clinic CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Kansas named
- Medical device recall Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens The affected products bear an incorrect statement on the carton packaging indicating that the product is “Indicated for Extended Wear”. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Kentucky and Michigan named
- Medical device recall Techno-Path Multichem AE Unassayed Level 1 A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall Techno-Path Multichem AE Unassayed Level 2 A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall Techno-Path Multichem AE Unassayed Level 3 A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall Ion Torrent Genexus Dx with software DNA or RNA sequencing system software has vulnerabilities. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Kentucky, Louisiana, Massachusetts, North Carolina, New York, Oklahoma and Pennsylvania named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico 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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