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 6, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall EGIA 45 ARTICULATING MED THICK SULU The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EGIA 45 ARTICULATING XTRA THICK SULU The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EGIA 60 ARTICULATING EXTRA THICK SULU The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EGIA45 CT AR MD THK REL, EGIA45CTAMT The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CIVCO Solstice(TM) SRS Immobilization System There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Florida, Hawaii, Kentucky, Pennsylvania and Wisconsin named
- Medical device recall Cepheid Xpert C Product is labeled with expiration date of 2021-10-31, should be 2021-03-31. Class IIIFDA’s classJun 26, 2019in FDA’s Enforcement Report11 statesnamed in where it went PublishedJun 26, 2019ClassClass IIIStatusOngoingWhereColorado, Georgia, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Tennessee and Texas
- Medical device recall LVivo EF app on Vscan Extend Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Minnesota, New York, South Carolina, Texas and Utah named
- Medical device recall LEEP Precision Integrated System 120V 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Indiana, Massachusetts, Michigan, Minnesota, North Carolina, Nevada, New York, Ohio, Texas, Washington and Wisconsin named
- Medical device recall ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide, and Iowa, New Jersey, Rhode Island, Texas and West Virginia named
- Medical device recall ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide, and Iowa, New Jersey, Rhode Island, Texas and West Virginia named
- Medical device recall Aquarius D13S319 Plus Deletion Probe There is an error in the chromomap on the package insert. Class IIIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJun 26, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Zenith Alpha Abdominal Endovascular Graft, Reference may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Mobi-C 14mm Distraction Screw, Quick Start Incorrect part description contained on an additional label placed on the packaging: A 14mm length part was incorrectly labeled as being a 12mm length screw Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1 The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1 The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AUTION HYBRID AU-4050 This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall IntraClude Intra-Aortic Occlusion Device Possibility of balloon rupture in intra-aortic occlusion devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 19, 2019ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F… There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Hampshire, New York, Oklahoma, Pennsylvania, Tennessee and Virginia named
- Medical device recall Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon… There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Hampshire, New York, Oklahoma, Pennsylvania, Tennessee and Virginia named
- Medical device recall Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Hampshire, New York, Oklahoma, Pennsylvania, Tennessee and Virginia named
- Medical device recall Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging… There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Hampshire, New York, Oklahoma, Pennsylvania, Tennessee and Virginia named
- Medical device recall Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum… There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Hampshire, New York, Oklahoma, Pennsylvania, Tennessee and Virginia named
- Medical device recall xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification… Reports have been received of lower MS2 MFI values when using the panel. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedJun 19, 2019ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Florida, Georgia, Illinois, Indiana, Missouri, North Carolina, North Dakota, New Jersey, New York, Oklahoma, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor… Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, Montana, New Mexico, New York, Ohio and Wisconsin named
- Medical device recall Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal… Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the… Class IIIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator:… Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the… Class IIIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall CardioCommand, Inc Possible corrosion of the battery contact(s). Class IIIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 19, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Connecticut, Delaware, Illinois and Ohio named
- Medical device recall InterStim(TM) System There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic’s smart… Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT) Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the… Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT) Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the… Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Getinge 86-Series-Medical Washer-Disinfector Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the… Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Illinois, Indiana, Michigan, North Carolina, Oregon, Pennsylvania and Virginia named
- Medical device recall Getinge 86-Series-Medical Washer-Disinfector Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the… Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Illinois, Indiana, Michigan, North Carolina, Oregon, Pennsylvania and Virginia named
- Medical device recall Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity… Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Iowa and Mississippi named
- Medical device recall Neff Percutaneous Access Set The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10 There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ECMO Reinforced Dual Lumen Cannula, Sterile EO Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2019in FDA’s Enforcement Report33 statesnamed in where it went PublishedJun 12, 2019ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah and Wisconsin
- Medical device recall ECMO Reinforced Dual Lumen Cannula, Sterile EO Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2019in FDA’s Enforcement Report33 statesnamed in where it went PublishedJun 12, 2019ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah and Wisconsin
- Medical device recall ECMO Reinforced Dual Lumen Cannula, Sterile EO Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2019in FDA’s Enforcement Report33 statesnamed in where it went PublishedJun 12, 2019ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah and Wisconsin
- Medical device recall ECMO Reinforced Dual Lumen Cannula, Sterile EO Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2019in FDA’s Enforcement Report33 statesnamed in where it went PublishedJun 12, 2019ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah and Wisconsin
- Medical device recall ECMO Reinforced Dual Lumen Cannula, Sterile EO Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2019in FDA’s Enforcement Report33 statesnamed in where it went PublishedJun 12, 2019ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah and Wisconsin
- Medical device recall ECMO Reinforced Dual Lumen Cannula, Sterile EO Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2019in FDA’s Enforcement Report33 statesnamed in where it went PublishedJun 12, 2019ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah and Wisconsin
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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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