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 DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular,… The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Ohio, Pennsylvania and West Virginia named
- Medical device recall Perceval Single Use Accessory Kit, Size S LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Maine, Minnesota, Missouri, Mississippi, North Carolina, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Perceval Single Use Accessory Kit, Size M LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Maine, Minnesota, Missouri, Mississippi, North Carolina, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Perceval Single Use Accessory Kit, Size S LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Maine, Minnesota, Missouri, Mississippi, North Carolina, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Perceval Single Use Accessory Kit, Size M LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Maine, Minnesota, Missouri, Mississippi, North Carolina, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Perceval Dual Collapser, Size S/M LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Maine, Minnesota, Missouri, Mississippi, North Carolina, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall EVOLVE STEM 8.5MM Lack of sterility assurance Class IIFDA’s classSep 30, 2020in FDA’s Enforcement Report9 statesnamed in where it went PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Massachusetts, Missouri, Ohio, Pennsylvania and Texas
- Medical device recall Panther Fusion Tube Tray, Part: FAB-15004 Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement Report25 statesnamed in where it went PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Massachusetts, Maine, North Carolina, New Jersey, New York, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall NM/CT 850 Model Number: H3907AD Rotor bearing screws were found loose on detector. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement Report27 statesnamed in where it went PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereArkansas, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall NM/CT 860, SPECT/CT Rotor bearing screws were found loose on detector. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement Report27 statesnamed in where it went PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereArkansas, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall NM/CT 870 CZT Rotor bearing screws were found loose on detector. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement Report27 statesnamed in where it went PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereArkansas, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall Discovery NM 630 Rotor bearing screws were found loose on detector. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement Report27 statesnamed in where it went PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereArkansas, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall NM 830 Model # H3910AC Rotor bearing screws were found loose on detector. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement Report27 statesnamed in where it went PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereArkansas, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall Discovery 670 DR Rotor bearing screws were found loose on detector. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement Report27 statesnamed in where it went PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereArkansas, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall Discovery NM670 Pro Rotor bearing screws were found loose on detector. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement Report27 statesnamed in where it went PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereArkansas, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall NM/CT 870 DR Rotor bearing screws were found loose on detector. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement Report27 statesnamed in where it went PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereArkansas, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall Speed Stitch Needle Cassette Due to a supplier error where a portion of the raw material was inadvertently mixed. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 30, 2020ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Smith&Nephew SmartStitch PerfectPasser Connector The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage… Class IIFDA’s classSep 30, 2020in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall CVS Advanced Wart Remover Kit Unit boxes not properly sealed Class IIIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 30, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Rhode Island named
- Medical device recall Personelle OTC Skin Tag Remover, Canada Unit boxes not properly sealed Class IIIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 30, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Rhode Island named
- Medical device recall Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Unit boxes not properly sealed Class IIIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 30, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Rhode Island named
- Medical device recall PrepIT Q2A Kit Reagents were shipped to customers after the Use by data indicated on its labeling. Class IIIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 30, 2020ClassClass IIIStatusTerminatedWhereNationwide, and California, Massachusetts, Maryland, Minnesota, New York, Pennsylvania and Texas named
- Medical device recall Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended… Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the… Class IIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Inquiry Steerable Diagnostic Catheter Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Indiana, Kentucky, Michigan, Missouri, Texas, Virginia and Wisconsin named
- Medical device recall Inquiry Steerable Diagnostic Catheter Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Indiana, Kentucky, Michigan, Missouri, Texas, Virginia and Wisconsin named
- Medical device recall Central Line Dressing Change Tray Potential of incomplete seals impacting the sterility of the kit. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 30, 2020ClassClass IIStatusTerminatedWhereMinnesota and Texas
- Medical device recall PrimeStore Molecular Transport Medium (PS-MTM) The tubes may have been delivered to some users without labels. Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 23, 2020ClassClass IIStatusOngoingWhereNationwide, and Maryland named
- Medical device recall 13 ft Handpiece Cable, component of the Dermatome Sets lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Indiana, Minnesota, Texas, Utah and West Virginia named
- Medical device recall Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in… lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Indiana, Minnesota, Texas, Utah and West Virginia named
- Medical device recall Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts… lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Indiana, Minnesota, Texas, Utah and West Virginia named
- Medical device recall NovaPACS Diagnostic Viewer The firm received a report of an atypical dataset being generated. Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Maquet/Getinge Rotaflow System Console US Instruction For Use (IFU) references incorrect serial number of 90437000. Class IIIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 23, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Maine, Nevada, New York, Ohio, Texas, Virginia and Washington named
- Medical device recall WallFlexTM Biliary RX Fully Covered Stent System RMV Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32 Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32 Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lactate Dehydrogenase L-P, (LDH) (NAO) An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and West Virginia named
- Medical device recall Lactate Dehydrognease P-L, (UV) An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and West Virginia named
- Medical device recall Zenith Alpha Abdominal Endovascular Graft May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in… Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples. Class IIFDA’s classSep 23, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereUtah, Virginia and West Virginia
- Medical device recall AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in… Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples. Class IIFDA’s classSep 23, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereUtah, Virginia and West Virginia
- Medical device recall Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AVANOS MIC-KEY SF Gastrostomy Feeding Tube Devices had cracked or detached from the feeding tube body Class IIFDA’s classSep 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereIllinois, Louisiana, New Jersey, Oklahoma, Pennsylvania, Texas and Wisconsin
- Medical device recall Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized… Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Imactis Patient Fiducial (Patient Referential) The firm has received reports concerning the patient fiducial disk separating from the body and users attempting to re-assemble the device. Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 23, 2020ClassClass IIStatusOngoingWhereNationwide, and Florida and Wisconsin 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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