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 7, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Novation XLE Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement Report22 statesnamed in where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereArkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0… Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement Report22 statesnamed in where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereArkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Potential that the induction seal is not completely sealed to the device tube packaging. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedFeb 19, 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, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Vios Monitoring System Bedside Monitor A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide, and New York named
- Medical device recall Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 12, 2025in FDA’s Enforcement Report15 statesnamed in where it went PublishedFeb 12, 2025ClassClass IStatusOngoingWhereCalifornia, Colorado, Georgia, Idaho, Michigan, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709) The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Discovery XR656HD The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Discovery XR656 HD The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Optima XR646 HD The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator.… There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 12, 2025in FDA’s Enforcement ReportMissourithe one state its words name PublishedFeb 12, 2025ClassClass IStatusOngoingWhereMissouri
- Medical device recall SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve… Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement Report39 statesnamed in where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereAlaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus… Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement Report39 statesnamed in where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereAlaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797 Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereCalifornia, Florida, Massachusetts, Nebraska, New Hampshire, Virginia and Washington
- Medical device recall Allura CV20 System Code: 722031 Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10 Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AlluraXper FD10/10 System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10C System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AlluraXper FD20 System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AlluraXper FD20 Biplane System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AlluraXper FD20 Biplane OR Table System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AlluraXper FD20 OR Table System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AlluraXperFD20/10 System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/20 System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AlluraXperFD20/15 System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 3 M12 System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 3 M15 System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 5 M12 System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 5 M20 System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 B12 System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 B20 System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 M12 System Code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 M20 System code Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection… Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall PROLENE Polypropylene Suture Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall PERMA-HAND Silk Suture Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall ETHIBOND EXCEL Polyester Suture Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2 Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1… Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, New Jersey, New York, Ohio, Pennsylvania, Utah, Virginia and Washington named
- Medical device recall LIFEPAK 35 ECG cable Product shipped with incorrect IFU. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Iowa, Indiana, Kentucky, Maryland, Michigan, Missouri, Nebraska, Nevada, New York, Ohio, Oregon, South Carolina, Tennessee, Texas and Wisconsin named
- Medical device recall Integra Miltex CryoSolutions Cartridges 10 Pack During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Integra Miltex Cryosolutions Cartridges 4 Pack During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 Due to nasal spray stability failure for bioburden. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall IntelliBridge EC10 Module Potential failure to alarm for “No Device Data” INOP. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereFlorida and North Carolina
- Medical device recall IntelliVue Patient Monitor MX400 Potential failure to alarm for “No Device Data” INOP. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereFlorida and North Carolina
- Medical device recall IntelliVue Patient Monitor MX450 Potential failure to alarm for “No Device Data” INOP. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereFlorida and North Carolina
- Medical device recall IntelliVue Patient Monitor MX500 Potential failure to alarm for “No Device Data” INOP. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereFlorida and North Carolina
- Medical device recall IntelliVue Patient Monitor MX550 Potential failure to alarm for “No Device Data” INOP. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereFlorida and North Carolina
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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