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 6, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula Due to customer complaint regarding incorrect display box labeling. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Affected lots may contain incorrect 0.8-micron filters. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: B B. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Brand Name: B B. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Brand Name: B B. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Brand Name: B B. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Brand Name: B B. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Brand Name: B B. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Brand Name: B B. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Brand Name: B B. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM Temperature probe devices lack FDA clearance. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Covidien Mon-a-Therm General Purpose Temperature Probe Temperature probe devices lack FDA clearance. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr Temperature probe devices lack FDA clearance. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) Potential for the Cassette Loading Lever to break. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall PhaseOne Antimicrobial Solution The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan, Mississippi, North Carolina, New Jersey, New York, Tennessee, Texas, Utah and Virginia named
- Medical device recall Spinal Needle procedure kits: Material Description (Material Number) 24GA These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number):… These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall CASE v7.0 Cardiac Testing System Electrical sparking may occur at the printer head. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Covidien EndoStitch” Polysorb Single Use Loading Unit The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Neptune Smart Docking Station It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required… Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Brand Name: HiResolution” Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Due to incorrect shelf-life expiration date. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, Tennessee, Washington and Wisconsin named
- Medical device recall Philips Azurion 3M12 During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Azurion 3M15 During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Azurion 5M12 During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Azurion 5M20 During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Azurion 7B12/12 During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Azurion 7B20/15 During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Azurion 7M12 During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Azurion 7M20 During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arvis Hip & Knee 3.0 Instrument Set The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, Nebraska, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Arvis Hip & Knee 2.0 Instrument Set The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, Nebraska, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Digital Angiography System Trinias:UD150G-40 / D150GC-40 Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not… Some of the Calibration/Output Certificates had the outputs reversed. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta… Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall BD Pyxis MedStation 4000 Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Pyxis MedStation ES Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Pyxis Anesthesia Station ES Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Pyxis Anesthesia Station 4000 Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 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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