Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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 7, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Directional Laser Probe with Alcon / Lumenis connector When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Colorado, Florida, Indiana, Maryland, North Carolina, New York, Ohio, Puerto Rico, South Carolina and Texas named
- Medical device recall Directional Laser Probe with Alcon / Lumenis connector When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Colorado, Florida, Indiana, Maryland, North Carolina, New York, Ohio, Puerto Rico, South Carolina and Texas named
- Medical device recall MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75” PG-Used for the percutaneous introduction of a guidewire… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75” PG-Used for the percutaneous introduction of a guidewire… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75” PG-Used for the percutaneous introduction of a… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75” PG-Used for the percutaneous introduction of a… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75” PG -Used for the percutaneous introduction of a guidewire… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75” PG Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75” PG-Used for the percutaneous introduction of a… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75” PG-Used for the percutaneous introduction of a… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75” PG- Used for the percutaneous introduction of a… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75” PG- Used for the percutaneous introduction of a… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75” PG-Used for the percutaneous introduction of a… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6” PG- Used for the percutaneous introduction of a guidewire… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6” PG- Used for the percutaneous introduction of a guidewire… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75” PG-Used for the percutaneous introduction of a… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6” PG- Used for the percutaneous introduction of a guidewire… Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall microStar Reader Permanent discontinuance of the microSTARii medical dosimetry system. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Convatec EsteemBody Soft Convex, Drainable Pouch Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action. Customer complaint received that reported the applier failed during surgery. Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Maine named
- Medical device recall D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action. Customer complaint received that reported the applier failed during surgery. Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Maine named
- Medical device recall D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action. Customer complaint received that reported the applier failed during surgery. Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Maine named
- Medical device recall Atellica IM Erythropoietin (EPO) Assay Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC… Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Iowa, Illinois, Michigan, Minnesota, North Carolina, Nebraska, Nevada, New York, Ohio and Texas named
- Medical device recall ADVIA Centaur Erythropoietin (EPO) Assay Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC… Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Iowa, Illinois, Michigan, Minnesota, North Carolina, Nebraska, Nevada, New York, Ohio and Texas named
- Medical device recall LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream… Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 20, 2024ClassClass IIStatusCompletedWhereNationwide, and New Jersey and Wisconsin named
- Medical device recall LVP software of the Ivenix Infusion System (IIS) Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled… Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 20, 2024ClassClass IIStatusCompletedWhereNationwide, and California, Colorado, New Jersey, Utah and Wisconsin named
- Medical device recall CERENOVUS CEREBASE DA Guide Sheath Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 20, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 20, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile Wrong product coloring. Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Maine named
- Medical device recall L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile Wrong product coloring. Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Maine named
- Medical device recall STERIS Boot Assembly, Traction Device, OT 1000 Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the… Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama named
- Medical device recall CARTO VIZIGO Bi-Directional Guiding Sheath Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process. Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall CLEARLINK Non-DEHP Solution Set Luer Lock Adapter Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks… Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Shimadzu, Trinias, Digital Angiography System Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function. Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall EasyPoint Needle, 25G x 5/8” The needle cannula of a retractable needle may detach from the needle holder in the patient. Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall BVI Visitec Irrigation Handle Pack and pouch label is missing the manufacturing and expiration date. Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CVS Health Waterproof Wound Tracking Dressing Product failed sterility testing. Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type… Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, New Jersey, Nevada, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type… Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, New Jersey, Nevada, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type… Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, New Jersey, Nevada, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type… Class IIFDA’s classMar 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMar 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, New Jersey, Nevada, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit… MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMar 13, 2024ClassClass IStatusOngoingWhereNationwide, 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 MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding… MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMar 13, 2024ClassClass IStatusOngoingWhereNationwide, 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 VITROS 3600 Immunodiagnostic System (New and Refurbished) Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS 5600 Integrated System (New and Refurbished) Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS XT7600 Integrated System Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Pyxis: MedStation ES Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash,… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedMar 13, 2024ClassClass 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, Northern Mariana Islands, 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 VITROS 3600 Immunodiagnostic System A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Missouri, Nebraska, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall VITROS 4600 Chemistry System A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the… Class IIFDA’s classMar 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMar 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Missouri, Nebraska, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Washington, Wisconsin and West Virginia 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.
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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