Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number… There is an increased likelihood of the introducer sheath separating at the proximal bond site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IStatusTerminatedWhereNationwide, 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, North Dakota, 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 Stimulan Kit 10cc The product is mislabeled. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Michigan, Minnesota, New Jersey, New York and Wisconsin named
- Medical device recall STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Michigan, Minnesota, New Jersey, New York and Wisconsin named
- Medical device recall STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Michigan, Minnesota, New Jersey, New York and Wisconsin named
- Medical device recall STOPCON Suction Valve-Suction Valve for GI-Endoscope Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Michigan, Minnesota, New Jersey, New York and Wisconsin named
- Medical device recall Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Michigan, Minnesota, New Jersey, New York and Wisconsin named
- Medical device recall Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water… Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Michigan, Minnesota, New Jersey, New York and Wisconsin named
- Medical device recall Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Michigan, Minnesota, New Jersey, New York and Wisconsin named
- Medical device recall Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Michigan, Minnesota, New Jersey, New York and Wisconsin named
- Medical device recall Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet… Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Michigan, Minnesota, New Jersey, New York and Wisconsin named
- Medical device recall ScopeValet Guardian Disposable Endoscope Valves Set Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Michigan, Minnesota, New Jersey, New York and Wisconsin named
- Medical device recall ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water… Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Michigan, Minnesota, New Jersey, New York and Wisconsin named
- Medical device recall Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament… Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament… Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CryoValve SG Pulmonary Human Heart Valve On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline… Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Missouri, Oklahoma and Texas named
- Medical device recall CryoPatch SG Pulmonary Human Cardiac Patch On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline… Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Missouri, Oklahoma and Texas named
- Medical device recall Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red) Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 30, 2020ClassClass IIStatusOngoingWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin and Wyoming
- Medical device recall Viral Transport Medium, 3ml There is a potential for contamination within Viral Transport Media. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall IceFORCE” 2.1 CX 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall IceFORCE” 2.1 CX Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall IceFORCE” 2.1 CX L 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall IcePearl” 2.1 CX 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall IcePearl” 2.1 CX Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall IcePearl” 2.1 CX L 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall IceRod” 1.5 CX 90¿ Cryoablation Needle¿ Complaint trend regarding needle shaft gas leaks. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall IceSphere” 1.5 CX 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall IceRod” 1.5 i-Thaw” Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusCompletedWhereNationwide
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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