Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, 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.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall IntraSight Mobile IVUS Systems Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following… Class IIIFDA’s classApr 20, 2022in FDA’s Enforcement Report14 statesnamed in where it went PublishedApr 20, 2022ClassClass IIIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Massachusetts, Maryland, Missouri, North Carolina, New York, Oregon, Pennsylvania, Tennessee and Texas
- Medical device recall Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves Product was distributed without being sterilized. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportGuamthe one state its words name PublishedApr 20, 2022ClassClass IIStatusCompletedWhereGuam
- Medical device recall Access-9 Large Bore Hemostasis Valves A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get… Class IIFDA’s classApr 20, 2022in FDA’s Enforcement Report49 statesnamed in where it went PublishedApr 20, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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 and West Virginia
- Medical device recall AccessPLUS Large Bore Hemostasis Valves A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get… Class IIFDA’s classApr 20, 2022in FDA’s Enforcement Report49 statesnamed in where it went PublishedApr 20, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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 and West Virginia
- Medical device recall Separation Technology Creamatocrit Plus The device was being marketed as an IVD without a 510(k). Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kentucky, Maryland, Minnesota, Missouri, North Carolina, Nevada, Oklahoma, Pennsylvania, South Dakota, Texas, Washington and Wisconsin named
- Medical device recall Integra Universal Flexible Arm Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 20, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, Florida, Georgia, Illinois, Massachusetts, Maryland, New York, Ohio, Oregon, Pennsylvania and Texas named
- Medical device recall Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing… Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing… Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing… Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing… Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nextra Hammertoe Correction System Driver Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing… Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy Pouch seals may be open, compromising sterility. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 20, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support Pouch seals may be open, compromising sterility. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 20, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller) Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. Class IIIFDA’s classApr 20, 2022in FDA’s Enforcement Report50 statesnamed in where it went PublishedApr 20, 2022ClassClass IIIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 Cub 2 Enclosed Bed Canopy System Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedApr 20, 2022ClassClass IStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall MUSE Cardiology Information System Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Verigene Processor SP Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 20, 2022ClassClass IIStatusOngoingWhereConnecticut, Louisiana and Texas
- Medical device recall 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 Due to an increase in complaint trend for leaks and intermittent/loose connections. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedApr 20, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall 20/30 Priority Pack Accessory Kit/.096 RHV Due to an increase in complaint trend for leaks and intermittent/loose connections. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedApr 20, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall 20/30 Priority Pack w/COPILOT Due to an increase in complaint trend for leaks and intermittent/loose connections. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedApr 20, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall INDEFLATOR Plus 30 Due to an increase in complaint trend for leaks and intermittent/loose connections. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedApr 20, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Plus 30 Priority Pack w/.096 RHV Due to an increase in complaint trend for leaks and intermittent/loose connections. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedApr 20, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the… Update to instructions for use regarding the cleaning and disinfection process for the reusable probes. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 20, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 Siemens Healthcare Diagnostics Inc. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536 Siemens Healthcare Diagnostics Inc. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 Siemens Healthcare Diagnostics Inc. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637 Siemens Healthcare Diagnostics Inc. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hydroxybutyrate LiquiColor Tests - includes 3 bottles Product was improperly store which may cause a delay in results. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement Report16 statesnamed in where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Indiana, Louisiana, Missouri, Mississippi, North Carolina, Nebraska, New York, Ohio, Pennsylvania, Virginia and Washington
- Medical device recall Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards The product was stored incorrectly due to improper storage controls which may lead to delayed results. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereAlabama, Florida, Nebraska, Ohio, Texas, Washington and Wisconsin
- Medical device recall Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head… Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally… Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Georgia, Massachusetts, Minnesota, North Carolina, New York, Ohio and Texas named
- Medical device recall CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma and Vermont named
- Medical device recall CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma and Vermont named
- Medical device recall CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma and Vermont named
- Medical device recall CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma and Vermont named
- Medical device recall CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma and Vermont named
- Medical device recall CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma and Vermont named
- Medical device recall Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box The mask cuff may disconnect from the device’s breathing tube. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1 Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 20, 2022ClassClass IIStatusCompletedWhereNationwide, and Arizona, District of Columbia, Florida, Kansas, Michigan, Minnesota, Ohio, Oklahoma, Pennsylvania and Virginia named
- Medical device recall Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384 Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the… Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall YSIO X.Pree For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Revolution Apex, Revolution CT with Apex Edition The accumulated dose is incorrectly displayed in certain situations. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Revolution CT, Revolution CT ES The accumulated dose is incorrectly displayed in certain situations. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Silatrix Oral Gel Polymerized Sucralfate Gel 10% Due to failure of microbial testing for total aerobic microbial count (TAMC). Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Florida and Georgia named
- Medical device recall Signa 1.5T TwinSpeed Magnetic Resonance Imaging System There is potential for the images to be flipped left to right. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD There is potential for the images to be flipped left to right. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGNA Excite 3T There is potential for the images to be flipped left to right. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile There is potential for the images to be flipped left to right. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass 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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