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 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall FreeStyle Libre 3 Plus Sensor Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 21, 2026in FDA’s Enforcement Report36 statesnamed in where it went PublishedJan 21, 2026ClassClass IStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods… Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medicrea, IB3D Universal Implant Inserter Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Minnesota, North Carolina, Ohio, Rhode Island, Tennessee, Texas and Virginia named
- Medical device recall Medicrea, IB3D PL Instruments Set Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Minnesota, North Carolina, Ohio, Rhode Island, Tennessee, Texas and Virginia named
- Medical device recall Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System. AIRO pendant replacement kits and upgrade do not possess the “Safe Hand Position Warning” label. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System. AIRO pendant replacement kits and upgrade do not possess the “Safe Hand Position Warning” label. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model… Boston Scientific is initiating the removal of certain batches of Coyote” Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Minnesota, New York, Ohio, Texas, Virginia and West Virginia named
- Medical device recall A71200 Vanta” Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200 Complaints received that Vanta A71200 CP App does not function as intended during use. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SMV DSX New Line, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SMV DSI, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SMV BodyTrack, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MAXXUS, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. Emphasizing instructions for LVP duration programming located in the IFU. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Medline Kits containing B Medline kits contain B. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing B Medline kits contain B. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing B Medline kits contain B. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing B Medline kits contain B. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing B Medline kits contain B. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing B Medline kits contain B. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing B Medline kits contain B. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing B Medline kits contain B. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing B Medline kits contain B. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing B Medline kits contain B. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing B Medline kits contain B. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing B Medline kits contain B. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Ready-to-Use Hydrophilic Catheter 14 Fr Labeling error, Incorrect expiration date Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall Product Name: Allura Xper FD10C Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10F Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10 Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10/10 Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 Biplane Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10 Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10/10 Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 Biplane Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 OR Table Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10 Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10/10 Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/10 Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/20 Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections,… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Philips Azurion Systems R3.0 Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: PALACOS Product Name: PALACOS R pro 40 increase of complaints regarding the breakage of the ampoules within their device systems. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: PALACOS Product Name: PALACOS R+G pro 40 increase of complaints regarding the breakage of the ampoules within their device systems. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: PALACOS Product Name: PALACOS MV+G pro 40 increase of complaints regarding the breakage of the ampoules within their device systems. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: PALACOS Product Name: PALACOS MV pro 40 increase of complaints regarding the breakage of the ampoules within their device systems. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 21, 2026ClassClass 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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