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 PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and… During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish… Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and… During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish… Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other… During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish… Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGNA Creator, SIGNA Explorer, NMRI systems For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brivo MR355, NMRI system For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Optima MR360, NMRI system For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGNA MR355, SIGNA MR360, NMRI system For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGNA MR380, NMRI system, Non-US Only For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Idaho and Ohio named
- Medical device recall ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide, and California and Kentucky named
- Medical device recall Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following… Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10/10 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 Biplane Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 Biplane OR Table Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 OR Table Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/10 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/15 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/20 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Allura CV20; Catalog numbers: 722031 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10C Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Azurion 3 M12 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Azurion 3 M15 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Azurion 5 M12 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Azurion 5 M20 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Azurion 7 B12 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Azurion 7 B20 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Azurion 7 M12 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Azurion 7 M20 Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardio Vascular-Allura Centron Possibility of the patient falling from the table related to the mattress used on the patient table. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Augustine Surgical Inc Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact . Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereAlabama, Nevada and Texas
- Medical device recall Augustine Surgical Inc Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact . Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereAlabama, Nevada and Texas
- Medical device recall Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397 Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereCalifornia
- Medical device recall DeRoyal AMG Suction Connector Tubing The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement Report21 statesnamed in where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, Georgia, Hawaii, Illinois, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Dakota, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall 3M Prevena Plus 125 Therapy Unit and System Kits Due to increase in complaints related to leak alarms Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 26, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit… Due to increase in complaints related to leak alarms Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 26, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Irix-A Integrated Lumbar Fusion System Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Louisiana, Ohio, Texas and West Virginia named
- Medical device recall AnchorFast Guard Select, Oral Endotracheal Tube Fastener Hollister received reports of decreased skin barrier wear time which could can lead to tube migration Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AnchorFast SlimFit, Oral Endotracheal Tube Fastener Hollister received reports of decreased skin barrier wear time which could can lead to tube migration Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AnchorFast, Oral Endotracheal Tube Fastener Hollister received reports of decreased skin barrier wear time which could can lead to tube migration Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AnchorFast Guard, Oral Endotracheal Tube Fastener Hollister received reports of decreased skin barrier wear time which could can lead to tube migration Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY Kits contain recalled components due to reports of reduced skin barrier wear time. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereCalifornia and New York
- Medical device recall Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2 Kits contain recalled components due to reports of reduced skin barrier wear time. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereCalifornia and New York
- Medical device recall LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass 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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