Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall VITROS 250 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 250AT Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 350 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5600 Integrated System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5600 Integrated System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 4600 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 4600 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5,1 FS Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5,1 FS Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Ingenuity CT In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall Ingenuity Core128 In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall Ingenuity Core In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall iCT, Model # 728306, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall iCT SP Model # 728311, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall Brilliance 64 In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall IQon Spectral CT In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall Ingenuity TF PET/CT In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall Vereos PET/CT In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall Lantis 6.1 Commander Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability Class IIFDA’s classAug 14, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, Illinois, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, West Virginia and Wyoming
- Medical device recall Lantis 8.3 Commander Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability Class IIFDA’s classAug 14, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, Illinois, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, West Virginia and Wyoming
- Medical device recall Lantis Commander Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability Class IIFDA’s classAug 14, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, Illinois, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, West Virginia and Wyoming
- Medical device recall Lantis system (pre-2003) Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability Class IIFDA’s classAug 14, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, Illinois, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, West Virginia and Wyoming
- Medical device recall Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W,… There is a potential that the image of one patient could get unexpectedly moved into another patient’s folder when the user is using the Edit functionality on… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall HYTEC 288 System Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 14, 2019ClassClass IIStatusOngoingWhereTexas
- Medical device recall The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassium (K+),… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Idaho, Illinois, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, New Jersey, New York, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall VITROS Chemistry Products GLU Slides-Product Code:1707801 Potentially Biased Results using VITROS Chemistry Products GLU Slides Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Kansas, Kentucky, Massachusetts, Minnesota and Tennessee named
- Medical device recall Endoscopic Cleaning Brushes Potential risk of brush detachment during cleaning. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, West Virginia and Wyoming named
- Medical device recall LSB Style Anchor Bolt On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows:… The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue… Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected Class IIFDA’s classAug 14, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereKentucky, New Jersey, Rhode Island, Texas and Washington
- Medical device recall Assayed Bovine Multi-Sera Level 1 The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1… Class IIIFDA’s classAug 14, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 14, 2019ClassClass IIIStatusTerminatedWhereArizona, Oregon, Washington and West Virginia
- Medical device recall Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent… Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereArkansas, Florida, Georgia, Maryland, Oklahoma and Virginia
- Medical device recall EnCor Breast Biopsy Probes There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall EnCor Breast Biopsy Probes There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall EnCor Breast Biopsy Probes There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall EnCor Breast Biopsy Probes There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall EnCor Breast Biopsy Probes There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall EnCor Breast Biopsy Probes There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits Tray label indicates the kits are packaged with a 15F “valved” peelable introducer, but the kits contain a 15F “non-valved” peelable introducer. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and West Virginia named
- Medical device recall 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits Tray label indicates the kits are packaged with a 15F “valved” peelable introducer, but the kits contain a 15F “non-valved” peelable introducer. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and West Virginia named
- Medical device recall 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits Tray label indicates the kits are packaged with a 15F “valved” peelable introducer, but the kits contain a 15F “non-valved” peelable introducer. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and West Virginia named
- Medical device recall The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a… Lasers/Catheters did not calibrate during set-up prior to use. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereCalifornia and Pennsylvania
- Medical device recall IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc,… The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Regard ¿ custom surgical pack labeled as “LAP - FLOL LADY OF ANGELS” including recalled Stryker Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 14, 2019ClassClass IIStatusOngoingWhereLouisiana and Missouri
- Medical device recall Regard ¿ custom surgical pack labeled as “LAPAROSCOPIC - OSU” including recalled Stryker Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 14, 2019ClassClass IIStatusOngoingWhereLouisiana and Missouri
- Medical device recall SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece) There was a higher than normal incidence rate of the blade not retracting when tightening. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
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.”
Your shortlist0 of 4
Add one more to compare.