Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system… An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be… Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide, and Tennessee named
- Medical device recall LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Illinois named
- Medical device recall PORTEX 0.5u HYDROPHOBIC DISC FILTER Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V Recent reports of patient infection. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in… Burrs (molding flash) on the cutter may tear the harvested vien Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GS70 Salus Surgical Table When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Michigan, Missouri, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall GS70H Salus Surgical Table When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Michigan, Missouri, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin… Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator… Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in… Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator… Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of… Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator… Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in… Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator… Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LIF AMP, Adjustable Awl Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set… Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New Jersey, Ohio, Texas and Utah named
- Medical device recall epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement Report26 statesnamed in where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New York, Ohio, Oklahoma, South Carolina, South Dakota and Texas
- Medical device recall epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement Report26 statesnamed in where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New York, Ohio, Oklahoma, South Carolina, South Dakota and Texas
- Medical device recall epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor… There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement Report26 statesnamed in where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New York, Ohio, Oklahoma, South Carolina, South Dakota and Texas
- Medical device recall PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance… Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Visera Hysterovideoscope Olympus HYF Type V IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah, Washington and Wisconsin named
- Medical device recall Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee… A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereGeorgia, Indiana and Texas
- Medical device recall Oculus Pentacam AXL Wave Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Massachusetts, Minnesota, North Carolina, New York, Ohio, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Oculus Pentacam AXL Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Massachusetts, Minnesota, North Carolina, New York, Ohio, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Oculus Myopia Master Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Massachusetts, Minnesota, North Carolina, New York, Ohio, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Wireless Foot Switch Loss of availability of the wireless foot switch during procedures. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Beckman Coulter, IVD Lipemic interference failed to meet the performance specification listed within the IFU. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery… It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for… Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 6, 2023ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, Louisiana, New Jersey, Oregon, Pennsylvania, South Carolina, South Dakota, Texas and Washington named
- Medical device recall Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Bronchovideoscope Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Airway Mobilescope, Models MAF-GM & MAF-TM. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Bronchovideoscope, Models BF-MP190F. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Bronchovideoscope, Models BF-XT190. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Bronchovideoscope, Models BF-P190 & BF-XP190. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Bronchovideoscope, Models BF-3C40 & BF-N20. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Bronchovideoscope, Models BF-3C160. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the… Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carina Sub-Acute Care Ventilator Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418,… Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain… Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BioFire Respiratory Panel 2.1 (RP2.1) Due to manufacturing issue, panels may result in false negative results. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement Report24 statesnamed in where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Utah and West Virginia
- Medical device recall FilmArray Pneumonia Panel (Pneumo) Due to manufacturing issue, panels may result in false negative results. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement Report24 statesnamed in where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Utah and West Virginia
- Medical device recall EMBLEM S-ICD Pulse Generator There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour… Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall EMBLEM MRI S-ICD Pulse Generator There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour… Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNo state 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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