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 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HAMILTON C1 Ventilator Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 2, 2023in FDA’s Enforcement Report50 statesnamed in where it went PublishedAug 2, 2023ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, 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 HAMILTON T1 Ventilator Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 2, 2023in FDA’s Enforcement Report50 statesnamed in where it went PublishedAug 2, 2023ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, 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 HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics,… Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 2, 2023in FDA’s Enforcement Report50 statesnamed in where it went PublishedAug 2, 2023ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, 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 HAMILTON C3 Ventilator Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 2, 2023in FDA’s Enforcement Report50 statesnamed in where it went PublishedAug 2, 2023ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, 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 QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid… If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that… Class IIFDA’s classAug 2, 2023in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, California, District of Columbia, Florida, Georgia, Idaho, Kansas, Kentucky, Maryland, Minnesota, New Jersey, New York, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall YAMATO PLUS IAB During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SENSATION 7 Fr During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in… During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in… During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in… During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation… During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SENSATION PLUS 8Fr During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in… During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation… During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). Class IIIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 2, 2023ClassClass IIIStatusOngoingWhereNationwide, and California named
- Medical device recall A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application.. When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the… Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs The case and each (i.e. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy… Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of… Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG… Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of… Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG… Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of… Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser… Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of… Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser… Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of… Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy… Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of… Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser… Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of… Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall vRad PACS with Mammography The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Maryland, Minnesota, Oklahoma, Tennessee and Texas named
- Medical device recall Trexo Device Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when… Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ringed DxI Reaction Vessels (RVs) Beckman Coulter, Inc. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Massachusetts, Michigan, North Carolina, New Jersey, Texas and West Virginia named
- Medical device recall FRED Flow Re-Direction Endoluminal Device Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Virginia and Washington named
- Medical device recall Argon Medical Devices There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy,… Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk… Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Kansas, Minnesota, North Carolina and New York named
- Medical device recall Ventralight ST 4” x 6” Ellipse with Echo PS Balloon may not inflate as intended. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ventralight ST 4.5” Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a… Balloon may not inflate as intended. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ventralight ST w Echo PS 4.5” Circle A low profile, bioresorbable, coated, permanent mesh, with a… Balloon may not inflate as intended. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ventralight ST w EchoPS 4”x6” Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a… Balloon may not inflate as intended. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab… Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated Class IIFDA’s classAug 2, 2023in FDA’s Enforcement Report10 statesnamed in where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereAlabama, California, District of Columbia, Florida, Georgia, Maine, North Carolina, New York, Oregon and Texas
- Medical device recall QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated Class IIFDA’s classAug 2, 2023in FDA’s Enforcement Report10 statesnamed in where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereAlabama, California, District of Columbia, Florida, Georgia, Maine, North Carolina, New York, Oregon and Texas
- Medical device recall Olympus OES BRONCHOFIBERSCOPE BF Type There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Olympus BRONCHOFIBERSCOPE BF Type There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Olympus BRONCHOVIDEOSCOPE BF Type There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Olympus BRONCHOVIDEOSCOPE There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
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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