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 Atellica CH Revised C-Reactive Protein (RCRP) The potential for falsely elevated results. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedSep 30, 2026ClassClass IStatusOngoingWhereNationwide, and Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Maryland, Michigan, Mississippi, New Jersey, New York, Ohio, Pennsylvania and Virginia named
- Medical device recall INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedSep 30, 2026ClassClass IStatusOngoingWhereNationwide, and Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Maryland, Michigan, Mississippi, New Jersey, New York, Ohio, Pennsylvania and Virginia named
- Medical device recall Halyard IV START KIT NON-STERILE Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 30, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm, Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse… A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse… A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse… A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse… A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve Labeling; Oxygen Cylinders do not contain required medical gas labeling Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Iowa, Nebraska, Ohio and Tennessee named
- Medical device recall REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver Labeling; Oxygen Cylinders do not contain required medical gas labeling Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Iowa, Nebraska, Ohio and Tennessee named
- Medical device recall REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve Labeling; Oxygen Cylinders do not contain required medical gas labeling Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Iowa, Nebraska, Ohio and Tennessee named
- Medical device recall PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm The proximal thread depth of the spinal device is out of design specification. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas and Virginia named
- Medical device recall Medline convenience kits containing Healthmark Instrument Channel Brushes Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota and South Dakota named
- Medical device recall Medline convenience kits containing Healthmark Instrument Channel Brushes Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota and South Dakota named
- Medical device recall VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe,… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 3.0T A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253 A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Evolution upgrade 1.5T and Evolution upgrade 3.0T A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Ambition S and Ingenia Ambition X A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 3.0T and Ingenia 3.0T CX A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Elition S and Ingenia Elition X A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Name (Model Number): 1 A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR 5300 Model Number (REF): 1. 782110, 2. 782152 A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR 7700 and Upgrade to MR 7700 A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath… A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens A small number of lenses within the affected lot are of the incorrect power. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota, Ohio and Wisconsin named
- Medical device recall Philips EPIQ Elite Diagnostic Ultrasound System Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood… Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Connecticut, Florida, Georgia, Kansas, Maryland, Minnesota, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall ForeSight Elite Tissue Oximetry Cable Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedSep 30, 2026ClassClass 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, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Automated Impella Controller (AIC) with the below product descriptions and corresponding Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT… Complaint trend where “Checkline Error” alarm presents at device setup, rendering the CO2 monitoring function inoperable. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Presource Convenience Kits: 1) KIT, PRE OP The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Kentucky, Missouri, North Carolina, Ohio and Texas named
- Medical device recall Presource Convenience Kits: 1) KIT, USGPIV The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Kentucky, Missouri, North Carolina, Ohio and Texas named
- Medical device recall REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series Myocardial temperature probes contain an incorrect needle. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Louisiana, Maryland, Missouri, Tennessee and Utah named
- Medical device recall Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Colorado and Florida named
- Medical device recall Cardioroot Woven Collagen Coated Vascular Graft Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large Gowns do not consistently meet the minimum liquid-barrier performance required. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide, and Connecticut named
- Medical device recall Halyard IV START KIT NON-STERILE Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass 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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