Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by… A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of… IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351 The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereCalifornia, Maryland, Nevada, Ohio, Texas and Wisconsin
- Medical device recall Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741 The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereCalifornia, Maryland, Nevada, Ohio, Texas and Wisconsin
- Medical device recall Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741 The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereCalifornia, Maryland, Nevada, Ohio, Texas and Wisconsin
- Medical device recall Biomet Modular Primary Tibial Tray Implants One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereFlorida, Georgia, Indiana, Massachusetts, New Mexico, Utah and Wisconsin
- Medical device recall Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereFlorida and Iowa
- Medical device recall Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereFlorida and Iowa
- Medical device recall Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereFlorida and Iowa
- Medical device recall Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vanguard Knee System PS Tibial Bearing The label master file was errantly set up as a 63/37mm instead of a 63/67mm. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Mississippi, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and West Virginia named
- Medical device recall CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96,… A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 20, 2018ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, North Carolina and New York named
- Medical device recall Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system The recalling firm identified four US lots of test strips out of specification. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accu-Chek Performa Test Strip, Blood glucose monitoring system The recalling firm has identified two lots of test strips that are out of specification. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accu-Chek Inform II Test Strip, Whole blood glucose test system The recalling firm has identified two lots of test strips that are out of specification. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall Bio-Stable 5F SL-55CM IR-145 Kit Valved PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS TANDEM 5F DL XPP A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS 5F DL XPP A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS - TANDEM 5F DL BIOFLO MIDLINE A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS 5F DL BIOFLO PICC A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS TANDEM 5F DL BIOFLO PASV A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS 5F DL BIOFLO PASV A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall TANDEM 5F DL BIOFLO PASV A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall 5F DL BIOFLO PASV A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS 5F DL BIOFLO PASV A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS 5F DL BIOFLO PASV A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall 5F DL BIOFLO PICC A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS 5F DL BIOFLO PASV A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS TANDEM 5F DL XCELA PICC PASV A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS 5F DL XPP KIT A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS 5F DL BIOFLO PASV A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS TANDEM 5F DL BIOFLO PASV A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS TANDEM 5F DL BIOFLO PICC A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall CAN 5F DL BIOFLO PASV PICC NURSING TRAY A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall CAN 5F SINGLE XCELA PICC A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall CAN 5F DUAL XCELA PICC A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
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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