Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Gentell Hydrogel Ag 4x8 During an FDA audit, it was discovered that the product was not properly registered with FDA. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 8, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Iowa, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas and Wisconsin named
- Medical device recall Gentell Hydrogel Ag 4oz During an FDA audit, it was discovered that the product was not properly registered with FDA. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 8, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Iowa, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas and Wisconsin named
- Medical device recall iTotal CR Knee Replacement System A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, New York and Tennessee named
- Medical device recall iTotal PS Knee Replacement System A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, New York and Tennessee named
- Medical device recall natus newborn care Olympic Brainz Monitor The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pharos Excimer Laser At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer laser phototherapy system causes the device to fail to cease… Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Mississippi, New York and Oregon named
- Medical device recall Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs. Pinion gear may disengage from track allowing lift to slip or jolt. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Indiana, Massachusetts, Maryland, Maine, Missouri, North Carolina, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall LifePAK 500 Automated External Defibrillator Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAVIO Soft Tissue Protector, included in instrument kits Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming… Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report21 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Ohio, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall AmniSure ROM Test, Material Nos An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which… Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Indiana, Missouri, North Carolina, New Hampshire, New York, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall ev3 Pipeline Flex Embolization Device Embolization device delivery system may fracture at the distal section during device implantation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ev3 Pipeline Flex Embolization Device with Shield Technology Embolization device delivery system may fracture at the distal section during device implantation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Honeywell Pressure Transducer The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Karl Storz NEURO-FIBERSCOPE During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement Report28 statesnamed in where it went PublishedApr 1, 2020ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Karl Storz, Model # 11161C2, Flexible Neuroscope During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement Report28 statesnamed in where it went PublishedApr 1, 2020ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement Report28 statesnamed in where it went PublishedApr 1, 2020ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Medtronic Open Pivot Aortic Valve Graft Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments,… The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall iChemVELOCITY Strips The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 1, 2020ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN:… Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN:… Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total… Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FlipCutter III Drill There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Comprehensive Shoulder System Mini Humeral Stem 9mm A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medline Stick Sponge Presaturated W/PVP Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming named
- Medical device recall Medline Winged Sponges Presaturated W/PVP Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming named
- Medical device recall Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming named
- Medical device recall Chemistry QC Premium Plus The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Delaware, Idaho, Indiana, Puerto Rico, Virginia and West Virginia named
- Medical device recall LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP) Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP) Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24 Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Wave Prep Tubes Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement Report18 statesnamed in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereAlabama, Arizona, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Missouri, New York, Ohio, Oklahoma, Oregon, Texas, Utah and Washington
- Medical device recall Omnipod DASH Personal Diabetes Manager (PDM) In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NaviCare Patient Safety Software Versions 3.5.400-3.9.300 There is a software issue which may result in failure to monitor or control patient’s bed exit mechanism. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereColorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia and Washington
- Medical device recall Imager II 5F Angiographic Catheters, 5 units per package. Potential for tip detachment of Imager II 5F Angiographic Catheters FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IStatusOngoingWhereNationwide
- Medical device recall Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144 Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement Report32 statesnamed in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Vermont
- Medical device recall Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement Report32 statesnamed in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Vermont
- Medical device recall FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810 Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement Report32 statesnamed in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Vermont
- Medical device recall Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint… During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Connecticut and New York named
- Medical device recall Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring… The company identified potential interference from hydroxyurea. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is… The company identified potential interference from hydroxyurea. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is… The company identified potential interference from hydroxyurea. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNo state 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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