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 (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM,… Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. Class IIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AquaBplus and AquaBplus B2 Water Purification System Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. Class IIFDA’s classOct 21, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 21, 2020ClassClass IIStatusTerminatedWhereDelaware, North Carolina, Oklahoma, Pennsylvania and Texas
- Medical device recall GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1 The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for… Class IIFDA’s classOct 21, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 21, 2020ClassClass IIStatusTerminatedWhereKansas, Minnesota and Virginia
- Medical device recall MediCult Vitrification Cooling Media There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. Class IIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 21, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of… Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a… Class IIFDA’s classOct 21, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 21, 2020ClassClass IIStatusOngoingWhereCalifornia, Delaware, Maryland, North Carolina, New Jersey, New York and Pennsylvania
- Medical device recall Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of… Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a… Class IIFDA’s classOct 21, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 21, 2020ClassClass IIStatusOngoingWhereCalifornia, Delaware, Maryland, North Carolina, New Jersey, New York and Pennsylvania
- Medical device recall Tina-quant Complement C4 ver.2 Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. Class IIIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Albumin Gen.2 Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. Class IIIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Percutaneous Neonatal Pigtail Nephrostomy Set, Reference The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. Class IIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pediatric Nephrostomy Stent Set, Reference The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. Class IIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks. Class IIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 21, 2020ClassClass IIStatusOngoingWhereNationwide, and California and Ohio named
- Medical device recall Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and… Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of… Class IIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 21, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SkyVision SDS System - Video Integration Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display… Class IIFDA’s classOct 21, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 21, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Iowa, Michigan, Minnesota, New York, Pennsylvania, Texas and Washington named
- Medical device recall DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel… Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Texas and Washington named
- Medical device recall MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a… Examination gloves were shipped inadvertently, without to verify barrier integrity. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the… Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate… Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Washington and Wisconsin named
- Medical device recall VERIGENE Processor SP No results/incorrect results due to failure of the hybridization heater. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportMissourithe one state its words name PublishedOct 14, 2020ClassClass IIStatusOngoingWhereMissouri
- Medical device recall Quick Release Gait Belt, 60 The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusOngoingWhereIllinois and Michigan
- Medical device recall Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and… Brainlab Ultrasound Navigation Software does not support the modification of the probe’s image width. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Idaho, Illinois, Massachusetts, Missouri, Oregon and Texas named
- Medical device recall Dual Mobility Vivacit-E Bearing The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report20 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereFlorida, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall ClearPro Closed Suction Catheter There have been reports of the suction catheter coming apart from the device assembly during use. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 1500 Flex Heat and Moisture Exchanger Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the closed respiratory circuit during use. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DJO EMPOWR Tibial Knee Punch Handle There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedOct 14, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Minnesota, Mississippi, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional… Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, New York, Ohio and Texas named
- Medical device recall Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and… Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, New York, Ohio and Texas named
- Medical device recall Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional… Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, New York, Ohio and Texas named
- Medical device recall Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and… Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, New York, Ohio and Texas named
- Medical device recall Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and… Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, New York, Ohio and Texas named
- Medical device recall Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional… Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, New York, Ohio and Texas named
- Medical device recall Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and… Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, New York, Ohio and Texas named
- Medical device recall Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR)… Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, New York, Ohio and Texas named
- Medical device recall NUVASIVE SPECIALIZED ORTHOPEDICS, INC During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Neoprobe GDS Control Unit It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. Class IIIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 14, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300… VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereArizona, Michigan, Mississippi, New Jersey and Pennsylvania
- Medical device recall Change Healthcare Radiology Solutions 14.0 Software defect which may potentially result in one or more images missing in a study Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereMississippi, Nebraska, Vermont and West Virginia
- Medical device recall BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may… Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereFlorida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee and Virginia
- Medical device recall BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may… Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereFlorida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee and Virginia
- Medical device recall CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may… Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereFlorida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee and Virginia
- Medical device recall CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may… Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereFlorida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee and Virginia
- Medical device recall CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may… Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereFlorida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee and Virginia
- Medical device recall CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may… Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereFlorida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee and Virginia
- Medical device recall CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may… Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereFlorida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee and Virginia
- Medical device recall Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm Dilation catheter packaged with the wrong size balloon. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Maryland, Missouri, North Carolina, Pennsylvania, South Dakota, Texas, Virginia and Wisconsin named
- Medical device recall Biomet Regenerex Primary Taper Cap Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomet OnPoint SCOPE PROCEDURE KIT Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomet ONPOINT SCOPE PROCEDURE KIT-EU Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomet ARTHROSIMPLICITY KIT EU Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized Class IIFDA’s classOct 14, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 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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