Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, 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 5, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm,… Septal Occluders contain the incorrect expiration date. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report47 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm,… Septal Occluders contain the incorrect expiration date. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report47 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm,… Septal Occluders contain the incorrect expiration date. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report47 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm,… Septal Occluders contain the incorrect expiration date. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report47 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm,… Septal Occluders contain the incorrect expiration date. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report47 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75… Septal Occluders contain the incorrect expiration date. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report47 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75… Septal Occluders contain the incorrect expiration date. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report47 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm,… Septal Occluders contain the incorrect expiration date. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report47 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall C315-HIS Delivery Catheter Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Concerto User Interface Software provided with the following systems If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save,… Class IIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Kentucky, Nevada, Oregon, Pennsylvania, Tennessee and Texas named
- Medical device recall Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series… The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and… Class IIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Florida, Illinois, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Utah and Wisconsin named
- Medical device recall ASC PneumoLiner device Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Florida, Illinois, Maryland, Michigan, Minnesota, Missouri, Nebraska, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Bivona Aire-Cuf Endotracheal Tube Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Kentucky, Massachusetts, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Virginia and Washington named
- Medical device recall Bivona Uncuffed Wire Endotracheal Tubes Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Kentucky, Massachusetts, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Virginia and Washington named
- Medical device recall BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton Holes in product packaging impacts package integrity and may compromise sterility. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement ReportTexasthe one state its words name PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and… Class IIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151 The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and… Class IIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Cardiosave Li-Ion Battery Pack A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall CADD-Solis VIP ambulatory infusion pump Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 27, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 27, 2021ClassClass IStatusTerminatedWhereNo state named
- Medical device recall VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the… VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Idaho, Kansas, Kentucky, Louisiana, Maine, Michigan, Missouri, Mississippi, New York, Tennessee, Texas and West Virginia named
- Medical device recall P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Maryland, New Jersey, Ohio, Pennsylvania, Tennessee, Texas, Utah and Virginia named
- Medical device recall MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194… Potential for mallet head to become separated from mallet handle. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusOngoingWhereFlorida and New Hampshire
- Medical device recall EPIQ CVxi Diagnostic Ultrasound Systems Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could… Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report18 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin
- Medical device recall Atellica IM 1300 Analyzer, SMN 11066001 Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of… Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report23 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusOngoingWhereArizona, California, Colorado, Georgia, Idaho, Kansas, Missouri, Montana, North Carolina, Nebraska, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Atellica IM 1600 Analyzer, SMN 11066000 Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of… Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report23 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusOngoingWhereArizona, California, Colorado, Georgia, Idaho, Kansas, Missouri, Montana, North Carolina, Nebraska, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Tenaculum, Plastic Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands and Washington named
- Medical device recall IUD Insertion Pack Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands and Washington named
- Medical device recall IUD Insertion Kit Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands and Washington named
- Medical device recall Endometrial Biopsy Kit Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands and Washington named
- Medical device recall Foundation Kit Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands and Washington named
- Medical device recall Standard IUD Insertion Kit Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands and Washington named
- Medical device recall SIGNA Premier nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, Texas, Virginia and Washington
- Medical device recall SIGNA Architect nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, Texas, Virginia and Washington
- Medical device recall SIGNA Pioneer nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, Texas, Virginia and Washington
- Medical device recall Discovery MR750w 3.0T nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, Texas, Virginia and Washington
- Medical device recall Discovery MR750 3.0T nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, Texas, Virginia and Washington
- Medical device recall SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, Texas, Virginia and Washington
- Medical device recall SIGNA Voyager nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, Texas, Virginia and Washington
- Medical device recall SIGNA Artist nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, Texas, Virginia and Washington
- Medical device recall Optima MR450w 1.5T nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, Texas, Virginia and Washington
- Medical device recall 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, Texas, Virginia and Washington
- Medical device recall Canon PET-CT SCANNER, Cartesion Prime A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start… Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Minnesota and Nevada named
- Medical device recall 6.5MMX165MM CANNULATED SCREW The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide, and Oklahoma and Tennessee named
- Medical device recall Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medical device recall Herniatome, 17G x 15cm, Lumbar Type The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medical device recall Herniatome, 17G x 9cm, Cervical Type The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medical device recall Kit: Central Line Dres Change 20/Cs The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportMichiganthe one state its words name PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereMichigan
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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