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 ICD-VR DVBC3D4 EVERA S DF4 GLOB There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVEX2E4 EV ICD OUS EV4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVFB1D1 VISIA AF MRI US DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVFB1D4 VISIA MRI AF US DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR VISIA MRI AF XT OUS DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR VISIA MRI AF S US/OUS DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVMB1D4 EVERA MRI XT DF4 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVMB2D1 EVERA MRI XT OUS DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVMD3D1 PRIMO MRI There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVMD3D4 PRIMO MRI There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVME3D1 MIRRO MRI There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-VR DVME3D4 MIRRO MRI There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD COBALT XT VR MRI IS1 DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD COBALT XT VR MRI DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD COBALT VR MRI IS1 DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD COBALT VR MRI DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD CROME VR MRI IS1 DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD CROME VR MRI DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ARROW Endurance Extended Dwell Peripheral Catheter System Potential for catheter separation or leakage FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Serrated Blade Applicator Kit Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). Class IIFDA’s classJun 28, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedJun 28, 2023ClassClass IIStatusOngoingWhereArkansas, California, Florida, Michigan, Nebraska, New York, Pennsylvania and Texas
- Medical device recall NextSeq 550Dx Instrument Cybersecurity vulnerability concerning the software used for sequencing instruments. Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IIStatusCompletedWhereNationwide
- Medical device recall MiSeq Dx Instrument Cybersecurity vulnerability concerning the software used for sequencing instruments. Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Hemospray Endoscopic Hemostat: Reference There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and… Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hemospray Endoscopic Hemostat: Reference There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and… Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall V-Sign Sensor 2 The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode “production” and were not reset to… Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 28, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Mississippi, Montana, Nevada and Texas named
- Medical device recall KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first… Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 28, 2023ClassClass 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, 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, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not… Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor TC-I tip clip sensor may produce readings outside the accuracy specification. Class IIFDA’s classJun 28, 2023in FDA’s Enforcement Report51 statesnamed in where it went PublishedJun 28, 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, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Masimo LNOP TC-I SpO2, Reusable Ear Sensor TC-I tip clip sensor may produce readings outside the accuracy specification. Class IIFDA’s classJun 28, 2023in FDA’s Enforcement Report51 statesnamed in where it went PublishedJun 28, 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, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Masimo LNCS TC-I SpO2, Reusable Ear Sensor TC-I tip clip sensor may produce readings outside the accuracy specification. Class IIFDA’s classJun 28, 2023in FDA’s Enforcement Report51 statesnamed in where it went PublishedJun 28, 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, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Masimo LNCS TC-I SpO2, Reusable Ear Sensor TC-I tip clip sensor may produce readings outside the accuracy specification. Class IIFDA’s classJun 28, 2023in FDA’s Enforcement Report51 statesnamed in where it went PublishedJun 28, 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, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or… Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or… Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or… Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or… Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Metal Tray, 178 x 135 x 37 mm Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first… Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJun 28, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C,… The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values. Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJun 28, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin named
- Medical device recall HeartWare Ventricular Assist Device System Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US),… Class IIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 28, 2023ClassClass IIStatusOngoingWhereNationwide, and Missouri, Texas and Virginia named
- Medical device recall NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device Device may experience malfunctions due to misalignment of the check valve in the manifold. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall p-Chip Wand Reader The laser operation might fall under a higher laser class. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Eye and Ear Dropper Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Hawaii, Illinois, Indiana, Missouri, North Carolina, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and Washington named
- Medical device recall Medicine Dropper Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJun 21, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Hawaii, Illinois, Indiana, Missouri, North Carolina, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and Washington 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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