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 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING &… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CHN OR DAVINCI PROSTATE Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB PACK Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1 Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000 The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100 Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present… Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJul 26, 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 GEM FLOW COUPLER Monitor, PN 5156-00000-011 An issue was identified where the LCD monitor display may not indicate the correct active channel. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall RET Proximal Probe DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Ohio and South Carolina named
- Medical device recall RET Distal Probe DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Ohio and South Carolina named
- Medical device recall Contour¿ next GEN Blood Glucose Monitoring System Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Missouri, New Jersey, New York, Ohio, Rhode Island, South Carolina, Tennessee, Texas and Virginia
- Medical device recall UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic… Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related… Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)--… The wrong tibia guide was included intended for a different patient case. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 26, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software Software issue Class IIFDA’s classJul 26, 2023in FDA’s Enforcement Report19 statesnamed in where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereAlaska, California, Georgia, Iowa, Illinois, Massachusetts, Maryland, Missouri, Nebraska, New Hampshire, New York, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Oxylog 3000 Plus emergency and transport ventilator Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall SIGMA Spectrum Infusion Pump A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall The Spectrum IQ Infusion System with Dose IQ Safety Software A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Kansas, Kentucky, Maryland, Missouri, Montana, Nebraska, New York, Tennessee and Texas named
- Medical device recall REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10 Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Kansas, Kentucky, Maryland, Missouri, Montana, Nebraska, New York, Tennessee and Texas named
- Medical device recall Allen Advance Chest Support with Pad Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Abbott Amplatzer Steerable Delivery Sheath (ASDS) There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage There is the potential for out of specification device geometries. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Georgia, Indiana, Minnesota, North Carolina, Nebraska, Ohio, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage There is the potential for out of specification device geometries. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Georgia, Indiana, Minnesota, North Carolina, Nebraska, Ohio, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage There is the potential for out of specification device geometries. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Georgia, Indiana, Minnesota, North Carolina, Nebraska, Ohio, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage There is the potential for out of specification device geometries. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Georgia, Indiana, Minnesota, North Carolina, Nebraska, Ohio, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage There is the potential for out of specification device geometries. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Georgia, Indiana, Minnesota, North Carolina, Nebraska, Ohio, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage There is the potential for out of specification device geometries. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Georgia, Indiana, Minnesota, North Carolina, Nebraska, Ohio, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage There is the potential for out of specification device geometries. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Georgia, Indiana, Minnesota, North Carolina, Nebraska, Ohio, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall GE Healthcare Vivid S60, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Vivid S70, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Vivid S60N, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Vivid S70N, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNo state 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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