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 5, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and… When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty… Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails Product may be mislabeled. Class IIFDA’s classNov 18, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Maryland, New Jersey and Ohio
- Medical device recall OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur) Product may be mislabeled. Class IIFDA’s classNov 18, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Maryland, New Jersey and Ohio
- Medical device recall OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia) Product may be mislabeled. Class IIFDA’s classNov 18, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Maryland, New Jersey and Ohio
- Medical device recall OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus) Product may be mislabeled. Class IIFDA’s classNov 18, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Maryland, New Jersey and Ohio
- Medical device recall Liberty Select Cycler Software Version 2.9.0 The device may detect an incorrect Heater Bag volume which may lead to a ‘Supply Bag Line Blocked’ alarm during treatment. Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 18, 2020ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medical device recall Strep B Carrot Broth One-Step, Ref Streptococcus culture medium contains an incorrect expiration date. Class IIIFDA’s classNov 18, 2020in FDA’s Enforcement Report22 statesnamed in where it went PublishedNov 18, 2020ClassClass IIIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Guam, Idaho, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New York, Puerto Rico, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Blood Monitoring Unit (BMU 40) The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Iowa, Maryland, North Carolina, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the… A high frequency output (2 MHz) has not been cleared for distribution in the U.S. Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Computed Tomography X-Ray System A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 18, 2020ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Computed Tomography X-Ray System A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 18, 2020ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Computed Tomography X-Ray System A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 18, 2020ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Positron Emission Tomography and Computed Tomography System A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 18, 2020ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular… Device malfunction causing the applier to jam, and clip loading failures. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 11, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Indiana, Missouri and Tennessee named
- Medical device recall Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional… Flow sensors could have damaged tubes in the form of small punctures or cuts. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement Report36 statesnamed in where it went PublishedNov 11, 2020ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation… Flow sensors could have damaged tubes in the form of small punctures or cuts. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement Report36 statesnamed in where it went PublishedNov 11, 2020ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation… Flow sensors could have damaged tubes in the form of small punctures or cuts. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement Report36 statesnamed in where it went PublishedNov 11, 2020ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall 9100c NXT system - Product Usage: Device is licensed and Flow sensors could have damaged tubes in the form of small punctures or cuts. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement Report36 statesnamed in where it went PublishedNov 11, 2020ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Flow Sensor Service Part Flow sensors could have damaged tubes in the form of small punctures or cuts. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement Report36 statesnamed in where it went PublishedNov 11, 2020ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Flow Sensor Service Part Flow sensors could have damaged tubes in the form of small punctures or cuts. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement Report36 statesnamed in where it went PublishedNov 11, 2020ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Flow Sensor Service Part Flow sensors could have damaged tubes in the form of small punctures or cuts. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement Report36 statesnamed in where it went PublishedNov 11, 2020ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall 3/8” FloPump, 32mL, (Sterile) The firm has become aware that they have distributed product that was expired. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Model 3300 LATITUDE Programming System with installed There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a… Class IIFDA’s classNov 11, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois and Texas
- Medical device recall Streamline MIS Navigation System Taps The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportMichiganthe one state its words name PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation The product did not receive pre-market approval or clearance. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement Report20 statesnamed in where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Jersey, Nevada, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Streamline OCT Navigated Instruments System does not include a drill guide. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportMichiganthe one state its words name PublishedNov 11, 2020ClassClass IIStatusOngoingWhereMichigan
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
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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