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 Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532… When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through… Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEGADYNE MEGA 2000 Patient Return Electrode Firm has received reports of patient burns in surgical procedures where device was used. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall MEGADYNE MEGA SOFT Reusable Patient Return Electrode Firm has received reports of patient burns in surgical procedures where device was used. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode Firm has received reports of patient burns in surgical procedures where device was used. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall MEGADYNE MEGA SOFT Pediatric Patient Return Electrode Firm has received reports of patient burns in surgical procedures where device was used. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall MEGADYNE MEGA SOFT Universal Patient Return Electrode Firm has received reports of patient burns in surgical procedures where device was used. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode Firm has received reports of patient burns in surgical procedures where device was used. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode Firm has received reports of patient burns in surgical procedures where device was used. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode Firm has received reports of patient burns in surgical procedures where device was used. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Perifix¿ / Epidural anesthesia kit Kits were assembled with the incorrect Filter Straw. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Design Options¿ / Epidural anesthesia kit Kits were assembled with the incorrect Filter Straw. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K,… When multiple processes are running on the watch’s Central Processing Unit (CPU), the application may fail unexpectedly. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K,… When multiple processes are running on the watch’s Central Processing Unit (CPU), the application may fail unexpectedly. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Voalte Patient Safety Baxter identified a potential risk where the “safety” monitoring and “bed exit” monitoring features may enter a permanent state of alert suppression. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, Georgia, North Carolina, Oregon, South Carolina, Tennessee and Virginia named
- Medical device recall NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed Baxter identified a potential risk where the “safety” monitoring and “bed exit” monitoring features may enter a permanent state of alert suppression. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, Georgia, North Carolina, Oregon, South Carolina, Tennessee and Virginia named
- Medical device recall Medtronic ILLUMISITE Platform Console Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in… Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide, and Illinois, Michigan, Missouri, North Dakota and Oklahoma named
- Medical device recall REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide, and Illinois, Michigan, Missouri, North Dakota and Oklahoma named
- Medical device recall AEQUALIS FLEX REVIVE Assembly Screw 0mm A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it… Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AEQUALIS FLEX REVIVE Assembly Screw 0mm Short A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it… Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the… Delay in reporting results due to Quality Controls running high outside of range. Class IIIFDA’s classJul 5, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 5, 2023ClassClass IIIStatusOngoingWhereCalifornia, Illinois, Puerto Rico, Virginia, Washington and Wisconsin
- Medical device recall Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor… Delay in reporting results due to Quality Controls running high outside of range. Class IIIFDA’s classJul 5, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 5, 2023ClassClass IIIStatusOngoingWhereCalifornia, Illinois, Puerto Rico, Virginia, Washington and Wisconsin
- Medical device recall Verigene Enteric Pathogens Nucleic Acid Test (EP) It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VERIGENE Clostridium difficile Nucleic Acid Test It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering… Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices… Class IIFDA’s classJul 5, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereCalifornia and Florida
- Medical device recall Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and… The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vanta with AdaptiveStim Implantable Neurostimulator A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall LEGACY SMARTBASE, NE 3.0D 1MML Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Idaho and Texas named
- Medical device recall Remel Haemophilus Test Medium (Agar) The test medium may not perform as intended. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Radiation therapy software, RayStation standalone software treatment planning system A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function… Class IIFDA’s classJul 5, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereArizona, California, Georgia and Washington
- Medical device recall EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is… Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250… Class IIFDA’s classJul 5, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereCalifornia, Michigan and New Jersey
- Medical device recall Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed… Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250… Class IIFDA’s classJul 5, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereCalifornia, Michigan and New Jersey
- Medical device recall DigitalDiagnost C90 There is a software login in issue that may prevent the user from logging in. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement Report9 statesnamed in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereArizona, Georgia, Iowa, Indiana, Minnesota, Nebraska, New Hampshire, Ohio and Texas
- Medical device recall Access Hybritech p2PSA reagent Reagent lot numbers include an insufficient concentration of blocking reagent. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement Report19 statesnamed in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, North Carolina, Nebraska, New Jersey, New York, Ohio, South Carolina, Tennessee, Texas, Utah and Washington
- Medical device recall RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief. There is the potential for the program software to malfunction which will not allow it to move forward to the next session. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedJul 5, 2023ClassClass IIStatusCompletedWhereNew York
- Medical device recall wDR 2.2 Mobile Digital Diagnostic X-Ray System There is a software login in issue that may prevent the user from logging in. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWherePuerto Rico and US Virgin Islands
- Medical device recall LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right The firm discovered through customer complaints that device segments may not meet specifications. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereAlabama, Georgia, Illinois, Indiana, Kansas, New Jersey, New York and Texas
- Medical device recall LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left The firm discovered through customer complaints that device segments may not meet specifications. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereAlabama, Georgia, Illinois, Indiana, Kansas, New Jersey, New York and Texas
- Medical device recall LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right The firm discovered through customer complaints that device segments may not meet specifications. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereAlabama, Georgia, Illinois, Indiana, Kansas, New Jersey, New York and Texas
- Medical device recall LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left The firm discovered through customer complaints that device segments may not meet specifications. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereAlabama, Georgia, Illinois, Indiana, Kansas, New Jersey, New York and Texas
- Medical device recall Exactech Shoulder GPS Impactor Handle The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereArkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Wisconsin
- Medical device recall Exactech Ergo Impactor Handle The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 5, 2023ClassClass IIStatusOngoingWhereArkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Minnesota, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Wisconsin
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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