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 ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for… Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or… Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package… Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments The incorrect IFU was distributed with the devices. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington, Wisconsin and West Virginia named
- Medical device recall Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can… Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member,… Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device… Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Connecticut, District of Columbia, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect Increased incidence of disposable tourniquet cuffs “not able to achieve desired pressure” and “not holding pressure” due to 1) Cuff fabric tearing during use,… Class IIFDA’s classApr 5, 2023in FDA’s Enforcement Report50 statesnamed in where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereAlaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Automated Peritoneal Dialysis System The electrical safety testing was not properly performed on the impacted devices and additional testing is required Class IIFDA’s classApr 5, 2023in FDA’s Enforcement Report10 statesnamed in where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, Florida, Illinois, North Dakota, New York, Ohio, Texas and Washington
- Medical device recall SMR TT Hybrid glenoid Std - Peg S Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct… Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportMissourithe one state its words name PublishedApr 5, 2023ClassClass IIStatusOngoingWhereMissouri
- Medical device recall COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement Report25 statesnamed in where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereAlaska, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Michigan, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall BD Pyxis Anesthesia ES System (PAS ES) Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or… Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMar 29, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM The subject product lots are being recalled because they received a higher than specified irradiation dose. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM The subject product lots are being recalled because they received a higher than specified irradiation dose. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM The subject product lots are being recalled because they received a higher than specified irradiation dose. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM The subject product lots are being recalled because they received a higher than specified irradiation dose. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM The subject product lots are being recalled because they received a higher than specified irradiation dose. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Low Flow Disposable Patient Circuit for the Precision Flow System There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow… Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Scan Monitor/ScanWatch A software bug eliminated the initial ECG activation and review of the ECG under a physician. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Raystation treatment planning system for radiation therapy It is possible to set a non-zero collimator angle in the Virtual Simulation module. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90 The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, New York, Utah and Wisconsin named
- Medical device recall DeRoyal SafeLiner Suction Canister, 1000cc The reason for the voluntary recall is due to shrinkage of the canister lid. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Illinois, Indiana, Missouri, North Carolina, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereArizona, Florida, Georgia, Michigan, Nebraska and Texas
- Medical device recall BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold. Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 22, 2023ClassClass IStatusTerminatedWhereNationwide, and Oklahoma named
- Medical device recall BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold. Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 22, 2023ClassClass IStatusTerminatedWhereNationwide, and Oklahoma named
- Medical device recall Recreo Hair Growth Laser Comb The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in… Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are… Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the… Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the… Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes… Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the… Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in… Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Fusion Bioline Vascular Graft One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to… Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Indiana, Louisiana, Michigan, Missouri, North Carolina, Nevada, New York, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Mississippi, Oregon and Texas named
- Medical device recall TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Mississippi, Oregon and Texas named
- Medical device recall TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Mississippi, Oregon and Texas named
- Medical device recall Plato 17 Microcatheter: Straight Tip, PL17-160-000 Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush,… Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, North Carolina, New Hampshire, Nevada, New York, Ohio, South Carolina, Texas, Utah and Wisconsin named
- Medical device recall Arial mobile application The mobile application for Android devices downloaded from the Google Play Store do not load per specifications and function on the Android devices. Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in… Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Georgia named
- Medical device recall In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in… Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Georgia named
- Medical device recall In Vitro Diagnostic (IVD) Panel FilmArray GI Panel Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in… Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Georgia named
- Medical device recall Amicus MNC Apheresis Kit Double Needle Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus… Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 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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