Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall ST-AIA PACK FSH Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK Prolactin Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK Estradiol Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK hsE2 Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK LH II Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK Prog II Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK SHBG Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK Testosterone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK Cort Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK HGH Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK Fer Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK IGE II Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK BMG Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK Cystatin C Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereFlorida, Michigan and New York
- Medical device recall Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a… Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that… Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus… Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE. Class IIIFDA’s classJun 13, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 13, 2018ClassClass IIIStatusTerminatedWhereAlabama, Oregon and Texas
- Medical device recall Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE. Class IIIFDA’s classJun 13, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 13, 2018ClassClass IIIStatusTerminatedWhereAlabama, Oregon and Texas
- Medical device recall Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE. Class IIIFDA’s classJun 13, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 13, 2018ClassClass IIIStatusTerminatedWhereAlabama, Oregon and Texas
- Medical device recall MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece,… The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled… Replacement of units lacking an updated device approval. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged… IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide, and Louisiana and Texas named
- Medical device recall NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters The bottles are mislabeled with an incorrect part number. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Iowa, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Pennsylvania, South Dakota, Texas and Wisconsin named
- Medical device recall Alaris Extension Sets with microbore tubing Reports of incorrect priming volume due to manufacturing with incorrect tubing. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Indiana, Kansas, Nebraska, New Jersey, Texas, Utah, Virginia and Washington
- Medical device recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and… The firm will be updating the Instructions for Use for the product. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product… The firm will be updating the Instructions for Use for the product. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bivona¿ Tracheostomy Tube Tracheostomy Tubes Carton labeling is printed with “Sterile” indicated labeling, however the device is not sold as sterile. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Idaho, New Jersey, New Mexico, Ohio and Virginia
- Medical device recall Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate… While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJun 13, 2018ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Rival Reduce Kit Plates, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Non-Locking Screw, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Locking Screw, D 2.0MM X 8MM, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Non-Locking Screw, D 2.7MM X 8MM, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Locking Screw, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Non-Locking Screw, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Locking Screw, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Box Plate, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall CC Plate, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Evans Plate, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall H-Plate, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Lapidus Plate, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall L-Plate, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall MTP Plate, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Straight Plate, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall TN Plate, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
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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