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 Total Hip Kit The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide, and Illinois named
- Medical device recall INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Illinois, Maryland, Minnesota, New York and Washington named
- Medical device recall ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of… Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HoverMatt, 39” W x 78” L 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the… Class IIFDA’s classAug 16, 2023in FDA’s Enforcement Report11 statesnamed in where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereArizona, California, Florida, Georgia, Hawaii, Idaho, Illinois, Massachusetts, Maryland, Rhode Island and Wisconsin
- Medical device recall Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to… The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system. Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to… During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly… Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly… Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly… Class IIFDA’s classAug 16, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF) Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Gore Tips Set Device Three lots of product may be labeled with an incorrect expiration day Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona named
- Medical device recall Equipment and table drapes Certain lots of the products have a Naphthalene odor. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Equipment and table drapes and Surgical Room Turnover (SRT) Kits Certain lots of the products have a Naphthalene odor. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Fusion Lithotripsy Extraction Basket Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Fusion Lithotripsy Extraction Basket Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for… Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement Report10 statesnamed in where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, Massachusetts, Maine, Missouri, New Jersey, New Mexico, New York, Oregon and Washington
- Medical device recall NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the… Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Kansas, Michigan, New York, Ohio, Pennsylvania and Texas named
- Medical device recall The following Pro.specta Emission Computed Tomography Systems that were During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereIdaho, Kansas, Massachusetts, New Hampshire, Ohio, Texas and Virginia
- Medical device recall MEGADYNE Suction Coagulators An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Incisive CT-Computed Tomography X-Ray System Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Incisive CT for Brazil SKD-Computed Tomography X-Ray System Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Incisive CT Power (China)-Computed Tomography X-Ray System Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Incisive CT Plus-Computed Tomography X-Ray System Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in… Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in… Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use… Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm… Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm… Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for… Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended… Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in… Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire,… Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ACCESSRAIL Platform (Standard Blade) The Standard Blade may not securely latch onto the Activator Drive. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ACROBAT SUV Vacuum Off-Pump System The Standard Blade may not securely latch onto the Activator Drive. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ACROBAT V Vacuum Off-Pump System The Standard Blade may not securely latch onto the Activator Drive. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ACROBAT-i Vacuum Stabilizer System The Standard Blade may not securely latch onto the Activator Drive. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OEC Flexiview 8800 Systems with 9-inch Image Intensifier Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved,… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 9, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OEC 9800 Systems with 9-inch Image Intensifier Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved,… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 9, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OEC 9900 Systems with 9-inch Image Intensifier Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved,… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 9, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OEC Elite Systems with 9-inch Image Intensifier Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved,… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 9, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved,… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 9, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNew York
- Medical device recall Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323 A higher than expected rate of thrombus formation or deposition has been observed. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedAug 9, 2023ClassClass IStatusOngoingWhereNationwide, and Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, South Carolina, Texas and Wisconsin named
- Medical device recall Covidien Cytosponge Cell Collection Device Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide, and Minnesota, New York, Virginia and Wisconsin named
- Medical device recall Allura Xper FD10 and FD20 The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 M20 The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to… The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass 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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