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 5, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington
- Medical device recall BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington
- Medical device recall BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington
- Medical device recall BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington
- Medical device recall BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington
- Medical device recall BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington
- Medical device recall BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington
- Medical device recall BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington
- Medical device recall BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington
- Medical device recall PICC Line Accessory Kit CVI4285 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PEDIATRIC PICC INSERTION TRAY CVI4450 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PEDIATRIC PICC INSERTION TRAY CVI4450A Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CVC BUNDLE WITHOUT CATH CVI4600 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PORT AND IO ACCESS DRESSING KIT DT15780A Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cap Change Kit DT20310 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Neonatal Cap Change Kit DT20315 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CAP CHANGE KIT DYNDC1496B Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INFUSA PORT KIT DYNDC1840E Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INFUSA PORT KIT DYNDC1840F Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STERILE CAP CHANGE KIT DYNDC1946B Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CAP BUNDLE KIT DYNDC2137 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRIPLE LUMEN BUNDLE KIT ECVC1540 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CVC BUNDLE, 20CM, 4L, PI ECVC5095 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CVC BUNDLE, 20CM, 3L, PI ECVC5120 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CVC BUNDLE, 20CM, 3L, PI ECVC5120A Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CVC BUNDLE MULTIMED, 3L, 20CM ECVC6060 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CENTRAL LINE BUNDLE ECVC6375 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545A Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OR VANTEX 7FR 3L 16CM CVC ECVC6665 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IV START KIT IV8440 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IV SECUREMENT KIT IVS3405 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IV KIT - SORBAVIEW IVS3475 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INVASIVE PROCEDURE TRAY MNS9510 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UVC TRAY UVT875 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR… Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall YUKON Polyaxial Screws Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report20 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Washington
- Medical device recall Achilles Insight Bone Sonometer Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Montana, North Carolina, New Jersey, New York, Ohio and Wisconsin named
- Medical device recall Achilles Express Bone Sonometer Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Montana, North Carolina, New Jersey, New York, Ohio and Wisconsin named
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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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