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 5, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Osstem Dental X-Ray System T1 Osstem Implant Co. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Osstem Dental X-Ray System T2 Osstem Implant Co. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Osstem Dental X-Ray System T2Plus Osstem Implant Co. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CODMAN Disposable Perforator 11mm Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall CODMAN Disposable Perforator 9mm Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Sentinel V11 Product Name: Sentinel V11 Due to two distinct issues: 1. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Minnesota named
- Medical device recall Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i” Certain… Incorrect titanium screw, packaged with dental implant. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Virginia and Washington
- Medical device recall Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement Report20 statesnamed in where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Kansas, Maryland, Michigan, North Carolina, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement Report20 statesnamed in where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Kansas, Maryland, Michigan, North Carolina, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington and Wisconsin
- Medical device recall TruDi¿ Navigation System - Multi Instrument Adapter It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MAHURKAR” Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch A potential issue with the seal integrity of header bag packaging. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MAHURKAR” Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch A potential issue with the seal integrity of header bag packaging. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MAHURKAR” Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch A potential issue with the seal integrity of header bag packaging. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MAHURKAR” Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch A potential issue with the seal integrity of header bag packaging. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MAHURKAR” Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch A potential issue with the seal integrity of header bag packaging. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MAHURKAR” Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12… A potential issue with the seal integrity of header bag packaging. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps… Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 12, 2025in FDA’s Enforcement Report53 statesnamed in where it went PublishedNov 12, 2025ClassClass IStatusOngoingWhereAlaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Beckman Coulter UniCel DxI 600 An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Beckman Coulter UniCel DxI 800 An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: Klassic BiPolar Head Potential packaging issue that could compromise the sterile barrier. Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, North Carolina, Ohio and Texas named
- Medical device recall Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version:… Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Colorado, Florida, Idaho, Illinois, Louisiana, Massachusetts, Michigan, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington, Wisconsin and West Virginia named
- Medical device recall 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300,… GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ultrasound System 1300, bkSpecto w/battery GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall UUltrasound System 2300, bkActiv w/battery GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall bk3000 Ultrasound System w/battery GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall bk3500 Ultrasound System w/battery GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall bk5000 Ultrasound System w/battery GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may… Class IIFDA’s classNov 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedNov 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Washington and West Virginia named
- Medical device recall IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Due to an identified manufacturing defect involving coating material lifting within the catheter’s distal inner diameter/lumen. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 5, 2025in FDA’s Enforcement Report12 statesnamed in where it went PublishedNov 5, 2025ClassClass IStatusOngoingWhereAlabama, California, Colorado, Connecticut, Florida, Illinois, Kentucky, Massachusetts, New York, Tennessee, Texas and Utah
- Medical device recall Brand Name: Alcon Laboratories, Inc Due to incomplete seals in the pouch which provide the sterile barrier. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: Alcon Laboratories, Inc Due to incomplete seals in the pouch which provide the sterile barrier. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: Alcon Laboratories, Inc Due to incomplete seals in the pouch which provide the sterile barrier. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: Alcon Laboratories, Inc Due to incomplete seals in the pouch which provide the sterile barrier. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: Alcon Laboratories, Inc Due to incomplete seals in the pouch which provide the sterile barrier. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER It was determined there is the potential of silicone fragments detaching from the yellow sealing component. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Connecticut, Maryland, Nebraska, New Mexico, New York, Oregon, Pennsylvania, Washington and Wisconsin named
- Medical device recall Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS It was determined there is the potential of silicone fragments detaching from the yellow sealing component. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Connecticut, Maryland, Nebraska, New Mexico, New York, Oregon, Pennsylvania, Washington and Wisconsin named
- Medical device recall Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS It was determined there is the potential of silicone fragments detaching from the yellow sealing component. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Connecticut, Maryland, Nebraska, New Mexico, New York, Oregon, Pennsylvania, Washington and Wisconsin named
- Medical device recall Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM It was determined there is the potential of silicone fragments detaching from the yellow sealing component. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Connecticut, Maryland, Nebraska, New Mexico, New York, Oregon, Pennsylvania, Washington and Wisconsin named
- Medical device recall Magseed Pro 7 cm soft tissue marker Potential for contamination with cotton fibers. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Indiana, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Texas and Washington named
- Medical device recall Magseed Pro 12 cm soft tissue marker Potential for contamination with cotton fibers. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Indiana, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Texas and Washington named
- Medical device recall Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM… A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 5, 2025ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Indiana, Kentucky, Michigan, Minnesota, New Jersey, New York, Pennsylvania, Texas and West Virginia named
- Medical device recall Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological… A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 5, 2025ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Indiana, Kentucky, Michigan, Minnesota, New Jersey, New York, Pennsylvania, Texas and West Virginia named
- Medical device recall Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging… A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 5, 2025ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Indiana, Kentucky, Michigan, Minnesota, New Jersey, New York, Pennsylvania, Texas and West Virginia 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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