Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total… Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total… Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total… Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total… Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total… Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw… Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion OB INSTRUMENT TRAY Trumpet Needle Guide ring can detach when excessive pressure is applied. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY Trumpet Needle Guide ring can detach when excessive pressure is applied. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, California, Georgia, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, Oregon, Rhode Island and Tennessee named
- Medical device recall 20 Gauge V-Lance Knife Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ClearCut Sideport Knife Dual Bevel 1.2mm Angled Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1 Potential for pressure wave data synchronization from two devices may not be correct. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Indiana and Oregon named
- Medical device recall BD Pyxis MedStation ES Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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 BD Pyxis MedStation 4000 System Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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 BD Pyxis” MedStation ES 7-Drawer Auxiliary Tower Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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 BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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 BD Pyxis” Anesthesia Station ES Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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 BD Pyxis(TM) Anesthesia Station 4000 Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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 RefleXion X1 Radiotherapy System A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereCalifornia, Connecticut, New Jersey, Oregon, Pennsylvania and Texas
- Medical device recall Brand Name: MEDLINE Product Name: SYR 30ML L/L Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Not yetclassified by FDAMay 29, 2024in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 29, 2024ClassNot yet classifiedStatusOngoingWhereCalifornia, Florida, Georgia, Illinois, Tennessee and Virginia
- Medical device recall Optum Nimbus II Plus Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall BiPAP V30 Auto Ventilator Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 29, 2024ClassClass IStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall BiPAP A40 Ventilators: BiPAP A40 Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 29, 2024ClassClass IStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall BiPAP A30 Ventilator Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 29, 2024ClassClass IStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series Non-medical laser products which were determined to not be in compliance with 21 C.F.R. Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Optical Inspection System, YSi series, YRi series Non-medical laser products which were determined to not be in compliance with 21 C.F.R. Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141… Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 1.5T Initial system The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 3.0T The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 3.0T TX for PET The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Evolution upgrade 3.0T The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 1.5T The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 1.5T S The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 3.0T CX The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Ambition S The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic… The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s… Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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