Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Calibrate CCX Interbody System for spinal fusion procedures: Implants Complaints have been received regarding post-operative implant collapse. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee and Utah named
- Medical device recall Infinity Central Station Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, American Samoa, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Nebraska, New York, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia and Washington named
- Medical device recall Brand Name: SenTiva” Product Name: VNS Therapy” SenTiva” Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: SenTiva DUO” Product Name: VNS Therapy¿ SenTiva DUO” Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall muRata Vios Monitoring System During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Maryland, New York, Ohio and Texas named
- Medical device recall Bodor P and C series laser cutting machines Non-compliant laser products Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit,… Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 29, 2025ClassClass IStatusOngoingWhereNationwide, and Arizona, Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Rhode Island, Texas, Utah and West Virginia named
- Medical device recall Otological Ventilation Tube - T-Tube 6mm - Silicone Lack of 510(k) clearance. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Otological Ventilation Tube - T-Tube 6mm - Double - Silicone Lack of 510(k) clearance. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Otological Ventilation Tube - T-Tube 9mm - Double - Silicone Lack of 510(k) clearance. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Otological Ventilation Tube - T-Tube 9mm - Silicone Lack of 510(k) clearance. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Otological Ventilation Tube - T-Tube 12mm - Silicone Lack of 510(k) clearance. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Otological Ventilation Tube - T-Tube 12mm - Double - Silicone Lack of 510(k) clearance. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Otological Ventilation Tube - Donaldson - Blue Silicone Lack of 510(k) clearance. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Otological Ventilation Tube - Donaldson - Double - Blue Silicone Lack of 510(k) clearance. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Pyxis MedStation ES (Med ES Main) Drawer and/or door failures that may lead to a delay in access to medications. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BD Pyxis MedStation ES AUX Drawer and/or door failures that may lead to a delay in access to medications. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BD Pyxis MedStation 4000 Main Drawer and/or door failures that may lead to a delay in access to medications. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BD Pyxis MedStation 4000 AUX Drawer and/or door failures that may lead to a delay in access to medications. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BD Pyxis Med ES Auxiliary (AUX) Drawer and/or door failures that may lead to a delay in access to medications. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BD Pyxis Med 4000 Auxiliary (AUX) Drawer and/or door failures that may lead to a delay in access to medications. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Rhode Island, South Carolina, Texas, Utah, Virginia and Wisconsin named
- Medical device recall CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Rhode Island, South Carolina, Texas, Utah, Virginia and Wisconsin named
- Medical device recall CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Rhode Island, South Carolina, Texas, Utah, Virginia and Wisconsin named
- Medical device recall The 3.0MM Neuro Match Head Soft Touch bur There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains… Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall stryker 3.0MM Neuro Match Head There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains… Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall stryker 3.0MM Precision Neuro Match Head There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains… Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: HALYARD Product Name: Laparotomy Pack Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New York, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall DLP Pediatric One-Piece Arterial Cannulae Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EOPA Arterial Cannula Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Select Series Angled Tip Arterial Cannula Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with… Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement Report13 statesnamed in where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Georgia, Illinois, Michigan, Minnesota, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Texas and Washington
- Medical device recall CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing… Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing… Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Microvention, Headway” 17 Advanced Straight Microcatheter with Hydrophilic Coating Sterility assurance; microcatheter inner packaging may contain incomplete seal. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35… The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat… The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20… The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35… The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35… The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45… The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45… The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45… The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20… The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20… The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM,… The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD PCR Cartridges used with MAX System Potential for signal drift in specific lots of BD PCR Cartridges. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming 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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