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 7, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance… It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product… It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LEGION AP Cutting Block Size 4 Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 5, 2020ClassClass IIStatusOngoingWhereIowa, North Carolina, Pennsylvania and Tennessee
- Medical device recall 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama and Idaho named
- Medical device recall 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama and Idaho named
- Medical device recall 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama and Idaho named
- Medical device recall 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama and Idaho named
- Medical device recall 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama and Idaho named
- Medical device recall Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage:… 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect… Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereArkansas, Arizona and Florida
- Medical device recall CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CS5/5+ Fastpacks, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Cell Saver¿5/5+ Bowl Kit Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CS Elite Processing Set Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CS Elite Processing Set Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CS Elite Fastpack, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components are intended to be… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are intended to be used for… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Japan CS Elite FASTPACK DISP Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are intended to be used for… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for… Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in… The products may have been packaged with an incorrect Instructions for Use. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Illinois, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in… The products may have been packaged with an incorrect Instructions for Use. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Illinois, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in… The products may have been packaged with an incorrect Instructions for Use. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Illinois, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for… The products may have been packaged with an incorrect Instructions for Use. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Illinois, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for… The products may have been packaged with an incorrect Instructions for Use. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Illinois, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for… The products may have been packaged with an incorrect Instructions for Use. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Illinois, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall iChemVELOCITY, Urine Chemistry System Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record… Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall iQ200 Series Urine Microscopy Analyzer Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record… Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584) The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY… ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereArkansas, Kansas, Missouri and Oklahoma
- Medical device recall Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide There is a potential for blockage of the Hub Attachment Tube. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BA-800M Chemistry Analyzer The gas spring on the front and rear protective cover may fail. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereMichigan and Texas
- Medical device recall ABS800 Chemistry Analyzer The gas spring on the front and rear protective cover may fail. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereMichigan and Texas
- Medical device recall Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical… Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Georgia, Iowa, Illinois, Kentucky, Michigan, Missouri, Montana, New Jersey, New York, Oregon and Tennessee named
- Medical device recall Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation… GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation… GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Illinois, Maine, Missouri, North Carolina, New York, Pennsylvania, Puerto Rico, Utah and Virginia named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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