Medical devices
Shortlist up to four to read them side by side.
2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall BD Pyxis Mini Main Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Pyxis MedStation ES Tower Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Pyxis MedBank Tower Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Pyxis MedBank Mini Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DeRoyal Industries Inc Sterile wound dressing, lacks sterility assurance Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida and North Carolina named
- Medical device recall MAC 5 A4 Resting ECG Analysis System 855001-001 Software in development inadvertently made available for customer use. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida and Georgia named
- Medical device recall Aligned Medical AMS16835 Fluids Kit RX Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Illinois and Virginia named
- Medical device recall TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Due to incorrect functional length on device labeling. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Maryland named
- Medical device recall Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide, and Michigan, Texas and Utah named
- Medical device recall Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions,… Class IIFDA’s classJun 10, 2026in FDA’s Enforcement Report49 statesnamed in where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U… Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2026in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJun 3, 2026ClassClass IStatusOngoingWherePuerto Rico
- Medical device recall Automated Impella Controller (AIC) A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJun 3, 2026ClassClass IStatusOngoingWhereNationwide, and California, Connecticut, Florida, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, North Dakota, New York, Ohio, Pennsylvania, Texas and Wyoming named
- Medical device recall Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.),… Nitrile Exam Glove failed to meet specifications chemical permeation performance. Class IIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 3, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Massachusetts, North Carolina, New Jersey and New York named
- Medical device recall Medline kits containing Huons Co Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 3, 2026ClassClass IStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall Medline kits containing Huons Co Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 3, 2026ClassClass IStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall Medline kits containing Huons Co Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 3, 2026ClassClass IStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall Medline kits containing Huons Co Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 3, 2026ClassClass IStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall Medline kits containing Huons Co Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 3, 2026ClassClass IStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall Medline kits containing Huons Co Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 3, 2026ClassClass IStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall Medline kits containing Huons Co Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 3, 2026ClassClass IStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall Automated Impella Controller (AIC) with the below product descriptions and corresponding Retrospective submission for following issues identified: 1. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall HydroMARK Breast Biopsy Site Marker Incorrect inner package labeling. Class IIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. Class IIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. Class IIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0… Class IIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0… Class IIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0… Class IIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0… Class IIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0… Class IIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE HealthCare ApexPro v6.0 eDelivery Software GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0… Class IIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Azurion system It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of… Class IIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura system It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of… Class IIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Class IIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 3, 2026ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5,… Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection,… Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 27, 2026ClassClass 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection,… Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 27, 2026ClassClass 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Swan-Ganz Pacing Catheter, Models: D200F7 Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection,… Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 27, 2026ClassClass 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Tangent Endoscopy, Tangent Single Use Digital Catheter Affected devices exhibited fractures at the distal shaft tip without complete detachment. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, North Carolina and Nevada named
- Medical device recall Oncology Kit w/60” Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak… Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Texas, Vermont, Washington and Wisconsin named
- Medical device recall OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7… Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the… Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Michigan, New York and Texas named
- Medical device recall Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR Certain lots of product have the potential for a sterile barrier breach. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR Certain lots of product have the potential for a sterile barrier breach. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR Certain lots of product have the potential for a sterile barrier breach. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR Certain lots of product have the potential for a sterile barrier breach. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR Certain lots of product have the potential for a sterile barrier breach. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR Certain lots of product have the potential for a sterile barrier breach. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR Certain lots of product have the potential for a sterile barrier breach. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR Certain lots of product have the potential for a sterile barrier breach. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR Certain lots of product have the potential for a sterile barrier breach. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass 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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