Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall ProSun Onyx 32 Sli Intensive ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Maine, Michigan, North Carolina, New Jersey, New York, Ohio, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall ProSun V3 42 Xlc(160w)(10 minutes) tanning bed ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Maine, Michigan, North Carolina, New Jersey, New York, Ohio, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall Olympus Diego Elite Console MDCONS 100 Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diego Elite Turbinate Blades Bipolar Blade, 4mm straight Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diego Elite Turbinate Blades Bipolar Blade, 4mm straight Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diego Elite Blades Monopolar, 4mm Straight, TIA Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diego Elite Malleable, 4mm Standard Monopolar Blades Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOPHEN UFH Control C2 The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. Class IIIFDA’s classApr 24, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 24, 2019ClassClass IIIStatusTerminatedWhereMichigan and Pennsylvania
- Medical device recall BIOPHEN UFH Control C1 The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. Class IIIFDA’s classApr 24, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 24, 2019ClassClass IIIStatusTerminatedWhereMichigan and Pennsylvania
- Medical device recall BIOPHEN LMWH Control C4 The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. Class IIIFDA’s classApr 24, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 24, 2019ClassClass IIIStatusTerminatedWhereMichigan and Pennsylvania
- Medical device recall Obturator (long cone) The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and Colorado, District of Columbia, Florida, Illinois, Maryland, Missouri, New York, Oklahoma, Pennsylvania, Texas and Virginia named
- Medical device recall Obturator (shortcone) The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and Colorado, District of Columbia, Florida, Illinois, Maryland, Missouri, New York, Oklahoma, Pennsylvania, Texas and Virginia named
- Medical device recall Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in… The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Illinois, Kentucky, Michigan and Texas named
- Medical device recall syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists… Software Issues. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully… The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Georgia, Maine, Minnesota, Missouri, New York, Oklahoma, South Carolina, Tennessee, Texas, Utah and Virginia named
- Medical device recall Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully… The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Georgia, Maine, Minnesota, Missouri, New York, Oklahoma, South Carolina, Tennessee, Texas, Utah and Virginia named
- Medical device recall Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use… Frayed pieces of the mounting card being inside the primary packaging. Class IIIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedApr 24, 2019ClassClass IIIStatusTerminatedWhereNationwide, and 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, 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 Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images… There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 24, 2019ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Michigan, New Mexico, Nevada, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational… There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 24, 2019ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Michigan, New Mexico, Nevada, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images… There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 24, 2019ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Michigan, New Mexico, Nevada, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Integra bioBLOCK Resorbable subtaler Implant, 10mm Temperature indicator may have changed color to dark gray or black prior to shipment. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and Michigan and Ohio named
- Medical device recall Integra bioBLOCK Resorbable subtaler Implant, 11mm Temperature indicator may have changed color to dark gray or black prior to shipment. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and Michigan and Ohio named
- Medical device recall Integra bioBLOCK Resorbable subtaler Implant, 12mm Temperature indicator may have changed color to dark gray or black prior to shipment. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and Michigan and Ohio named
- Medical device recall SORIN Heater-Cooler System 3T For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM). Class IIFDA’s classApr 17, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereIndiana, Missouri and Ohio
- Medical device recall Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the… Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is… There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is… There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is… There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Immunoassay Premium Controls The target value for uptake is incorrect on the value sheet for an analyzer. Class IIIFDA’s classApr 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 17, 2019ClassClass IIIStatusTerminatedWherePuerto Rico and West Virginia
- Medical device recall Immunoassay Premium Plus Controls The target value for uptake is incorrect on the value sheet for an analyzer. Class IIIFDA’s classApr 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 17, 2019ClassClass IIIStatusTerminatedWherePuerto Rico and West Virginia
- Medical device recall Liquid Immunoassay Premium Controls The target value for uptake is incorrect on the value sheet for an analyzer. Class IIIFDA’s classApr 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 17, 2019ClassClass IIIStatusTerminatedWherePuerto Rico and West Virginia
- Medical device recall iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.)… The kits were prepared with incorrect patient ID labels and may contain incorrect components. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and North Carolina named
- Medical device recall Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance… Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the… Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and New York, Texas and Wisconsin 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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