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 6, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010 Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020 Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and… Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Micro Joystick R-net Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide, and Texas named
- Medical device recall Multi Joystick R-net Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide, and Texas named
- Medical device recall IDM-MICRO-R. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide, and Texas named
- Medical device recall IDM-MULTI-R. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide, and Texas named
- Medical device recall All-round Joystick R-net Light Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide, and Texas named
- Medical device recall IDM-ARLITE-R Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide, and Texas named
- Medical device recall DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR The catheters may not retain their shape. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR The catheters may not retain their shape. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR The catheters may not retain their shape. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion… As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance… Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall RefleXion X1 Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead… Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Louisiana, New Jersey, Oregon, Pennsylvania and Texas named
- Medical device recall RayStation with the following product descriptions: 1 DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, South Carolina, Washington and Wisconsin named
- Medical device recall RayStation with the following product descriptions: 1 DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, South Carolina, Washington and Wisconsin named
- Medical device recall RayStation with the following product descriptions: 1 DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, South Carolina, Washington and Wisconsin named
- Medical device recall RayStation with the following product descriptions: 1 DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, South Carolina, Washington and Wisconsin named
- Medical device recall RayStation with the following product descriptions: 1 DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, South Carolina, Washington and Wisconsin named
- Medical device recall RayStation with the following product descriptions: 1 DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, South Carolina, Washington and Wisconsin named
- Medical device recall RayStation with the following product descriptions: 1 DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, South Carolina, Washington and Wisconsin named
- Medical device recall RayStation with the following product descriptions: 1 DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, South Carolina, Washington and Wisconsin named
- Medical device recall RayStation with the following product descriptions: 1 DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, South Carolina, Washington and Wisconsin named
- Medical device recall InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) Medtronic MiniMed, Inc. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall LIFEPAK 15 Part / Due to required inspections not being performed on products/units that have gone through servicing. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Colorado and Montana named
- Medical device recall LIFEPAK 1000 Part / Due to required inspections not being performed on products/units that have gone through servicing. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Colorado and Montana named
- Medical device recall LIFEPAK CR2 Part / Due to required inspections not being performed on products/units that have gone through servicing. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Colorado and Montana named
- Medical device recall Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and… Due to products distributed without premarket clearance or approvals. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and California and Michigan named
- Medical device recall Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and… Due to products distributed without premarket clearance or approvals. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and California and Michigan named
- Medical device recall Philips Azurion System configured with a 1 Phase UPS Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if… Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Allura System configured with a 1 Phase UPS Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if… Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia named
- Medical device recall Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Packaging failures were identified which could lead to a breach in the sterile barrier. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Packaging failures were identified which could lead to a breach in the sterile barrier. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Packaging failures were identified which could lead to a breach in the sterile barrier. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Packaging failures were identified which could lead to a breach in the sterile barrier. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Packaging failures were identified which could lead to a breach in the sterile barrier. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Packaging failures were identified which could lead to a breach in the sterile barrier. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Packaging failures were identified which could lead to a breach in the sterile barrier. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Packaging failures were identified which could lead to a breach in the sterile barrier. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Medshape Universal Joints Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery… Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Iowa, Illinois, Indiana, Massachusetts, Montana, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on… Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, New York, Ohio and Pennsylvania named
- Medical device recall Platelia Toxo IgM Due to a risk of false positive results that could lead to unnecessary medical treatment. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, North Carolina and Nevada 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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