Medical devices
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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 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall GEM Premier 5000 Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Due to pediatric defibrillator electrode delamination Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Owner’s Booklets and Instructions for Use that are used with the following blood glucose measuring devices The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Owner’s Booklets and Instructions for Use that are used with the following blood glucose measurement devices The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Owner’s Booklets and Instructions for Use that are used with the following blood glucose measuring devices The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Owner’s Booklets and Instructions for Use that are used with the following blood glucose measuring devices The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Indiana and Pennsylvania named
- Medical device recall Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Indiana and Pennsylvania named
- Medical device recall EndoVive Safety PEG Kit Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxC 700 AU, REF: B86444, B86446 A delay in results may occur. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall CHEMISTRY ANALYZER AU5800 A delay in results may occur. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Artelon FlexBand Dynamic Matrix Augmentation devices failed bacterial endotoxin testing. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Artelon FlexBand Plus Augmentation devices failed bacterial endotoxin testing. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Artelon FLEXBAND TWIST .12 Augmentation devices failed bacterial endotoxin testing. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall HealthCast “Vital Sync” Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P /… Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall CLARITY II Laser System Reports of devices sparking/popping and potentially burning patients. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Wondfo Streptococcal A At-Home Self-Test Product not cleared by the FDA. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Clearest Strep-A Cassette Test Product not cleared by the FDA. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Bisaf Strep A Self-Test Product not cleared by the FDA. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL… Fabric may experience premature delamination when using included laundering instructions. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN… Fabric may experience premature delamination when using included laundering instructions. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella RP with SmartAssist Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Impella RP Flex with SmartAssist Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Impella RP. Product Code: 0046-0011. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall GE Healthcare Centricity Universal Viewer Zero Footprint Client Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP)… Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material… Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable… Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single… Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EVO+ Visian Toric Implantable Collamer Lens (TICL) Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so… Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: B The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Brand Name: B The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Brand Name: B The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Atellica CH Urine Albumin (UAlb) Falsely depressed UAlb patient results may occur. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM There is the potential for the length of the trocar shaft to be too long. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah and Washington named
- Medical device recall CS100 IABP. Software Version CS100 IABP Q.01. The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CS300 IABP. Software Version CS300 IABP C.01. The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Single use Biopsy Valve Potential for rubber fragment detachment during use. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Single Use Biopsy Valve Potential for rubber fragment detachment during use. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Esaote Endocavity ultrasonic probe A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near… Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 11, 2026ClassClass IIStatusCompletedWhereNationwide, and North Carolina and Texas named
- Medical device recall Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kentucky, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington 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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