Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall DuraLife Autoclavable Silicone Extension Tube DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs.,… Some of the tubes may be incorrectly labeled. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 24, 2023ClassClass IIStatusCompletedWhereNationwide, and Georgia and Wisconsin named
- Medical device recall Spectral CT 7500 Computed Tomography X-Ray System Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, Indiana, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania and Texas named
- Medical device recall Philips Incisive CT -Computed Tomography X-Ray System Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Illinois, Indiana, Michigan, Missouri, New York, Tennessee, Texas and Vermont named
- Medical device recall Philips Incisive CT -Computed Tomography X-Ray System Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Illinois, Indiana, Michigan, Missouri, New York, Tennessee, Texas and Vermont named
- Medical device recall ProxiDiagnost N90 R.1.0 Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CombiDiagnost R90 R.1.0 Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CombiDiagnost R90 R1.1 Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s… The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic… Due to a manufacturing issue that may result in filter leakage. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package) The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall WATCHDOG ACCESSORY KIT The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall DxU 850m Iris Urine Microscopy Analyzer Beckman Coulter has become aware of an intermittent issue in which the optional flag “Previous Sample Had Sperm” was enabled but not displayed so that a… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall DxU 840m Iris Urine Microscopy Analyzer Beckman Coulter has become aware of an intermittent issue in which the optional flag “Previous Sample Had Sperm” was enabled but not displayed so that a… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall UA WIN 10 Kit Beckman Coulter has become aware of an intermittent issue in which the optional flag “Previous Sample Had Sperm” was enabled but not displayed so that a… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Fisher Wallace Stimulator Models FW-100 and FW-200 If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall YelloPort Elite Optical Trocars sterility assurance can not be guaranteed Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedMay 24, 2023ClassClass IIStatusOngoingWhereMassachusetts
- Medical device recall YelloPort Elite Optical Trocars sterility assurance can not be guaranteed Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedMay 24, 2023ClassClass IIStatusOngoingWhereMassachusetts
- Medical device recall Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of… Marketed without a 510k Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 24, 2023ClassClass IIStatusCompletedWhereNationwide, and California, Illinois, North Carolina, New Hampshire and Oregon named
- Medical device recall ET III Nano-HA fixture System ET NH Dental Implant Mis-labeled length of the dental implant on the Recall Implant’s package. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereFlorida, Tennessee and Texas
- Medical device recall Beckman Coulter Bicarbonate There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 24, 2023ClassClass 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, 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 Beckman Coulter Bicarbonate There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 24, 2023ClassClass 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, 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 Beckman Coulter Bicarbonate There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 24, 2023ClassClass 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, 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 Attest Steam Chemical Integrators 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 3M Attest Steam Chemical Integrators 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat The product contains an expired diluent vial. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12” Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedMay 24, 2023ClassClass IIStatusOngoingWhereWashington
- Medical device recall Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ANGIOGUARD RX / XP Emboli Capture Guidewire System There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall Bard Mission Disposable Core Biopsy Instrument Kit Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle… Class IIFDA’s classMay 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 17, 2023ClassClass 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 Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for… Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient’s body. Class IIFDA’s classMay 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 17, 2023ClassClass IIStatusOngoingWhereNationwide, and Ohio 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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