Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall Soluble Transferrin Receptors (STFR) A customer reported a problem with the reagent and calibrator. Class IIIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 27, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Soluble Transferrin Receptors Calibrator Series (STFR CAL) A customer reported a problem with the reagent and calibrator. Class IIIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 27, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and Maryland, Montana, Oregon, Puerto Rico and West Virginia named
- Medical device recall Sensis with software version VD12A Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, Florida, Kentucky, Michigan, Ohio, Puerto Rico and Texas named
- Medical device recall Sensis Vibe Combo with software version VD12A Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, Florida, Kentucky, Michigan, Ohio, Puerto Rico and Texas named
- Medical device recall GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000 The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement Report28 statesnamed in where it went PublishedJul 27, 2022ClassClass IIStatusOngoingWhereArizona, California, Colorado, Connecticut, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and West Virginia
- Medical device recall ENNOVATE MIS REMOVALKEY SHORT Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Michigan, Ohio and Texas named
- Medical device recall ENNOVATE MIS REMOVALKEY SHORT Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Michigan, New Hampshire, Ohio, South Carolina and Texas named
- Medical device recall SIGNA Premier magnetic resonance scanner Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Michigan, Minnesota, New York and Wisconsin named
- Medical device recall BD Connecta Stopcock with OFF Directed Tap Without Extension Tube May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall BD Connecta Stopcock Without Extension Tube May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall BD Connecta Stopcock Without Extension Tube May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall BD Connecta Stopcock Without Extension Tube May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall BD Connecta Stopcock Without Extension Tube May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall BD Connecta 3-Way Stopcocks May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall BD Connecta” Plus1 360 Blue Blend May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall BD Connecta White 360 Shelf 100Ea May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall BD Connecta” Plus3 White Blend OEM (sterile, bulk) May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Nexiva with Single BD Connecta Stopcock Version (Pink) May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Nexiva with Single BD Connecta Stopcock Version May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJul 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Indiana, Michigan, North Carolina, Nevada, Ohio, Pennsylvania, South Carolina, Texas and Wyoming named
- Medical device recall AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Indiana, Michigan, North Carolina, Nevada, Ohio, Pennsylvania, South Carolina, Texas and Wyoming named
- Medical device recall AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Indiana, Michigan, North Carolina, Nevada, Ohio, Pennsylvania, South Carolina, Texas and Wyoming named
- Medical device recall AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Indiana, Michigan, North Carolina, Nevada, Ohio, Pennsylvania, South Carolina, Texas and Wyoming named
- Medical device recall AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Indiana, Michigan, North Carolina, Nevada, Ohio, Pennsylvania, South Carolina, Texas and Wyoming named
- Medical device recall AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Indiana, Michigan, North Carolina, Nevada, Ohio, Pennsylvania, South Carolina, Texas and Wyoming named
- Medical device recall Aesculap Sterile disposable fleece drape Packaging seal integrity not validated resulting in a lack of sterility assurance. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement Report14 statesnamed in where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Georgia, Illinois, Indiana, Kentucky, Michigan, North Carolina, Nebraska, New York, Ohio, Rhode Island, Virginia and Wisconsin
- Medical device recall LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Massachusetts, Maryland, North Carolina, New Jersey, Nevada, New York, Oklahoma, Tennessee, Texas and Wisconsin
- Medical device recall LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Massachusetts, Maryland, North Carolina, New Jersey, Nevada, New York, Oklahoma, Tennessee, Texas and Wisconsin
- Medical device recall SurgiCount+ System Application, Software Version 2.0.17 When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and… Class IIFDA’s classJul 27, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereKansas and Maine
- Medical device recall ProxiDiagnost N90 Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost 4 High Performance Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost 4 Flex / Value Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost C90 High Performance Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost C90 Flex/Value/Chest/ER Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CoolMax ZELTIQ Vacuum Applicator Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CoolCore ZELTIQ Vacuum Applicator Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CoolCurve ZELTIQ Vaccum Applicator Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CoolCurve+ ZELTIQ Vacuum Applicator Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CoolFit ZELTIQ Vacuum Applicator Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Philips Laser System The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report27 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall MiniMed 620G Insulin Pump (O.U.S Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MiniMed 630G Insulin Pump (U.S Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MiniMed 640G Insulin Pump (O.U.S Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MiniMed 670G Insulin Pump (U.S Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MiniMed 720G Insulin Pump (O.U.S Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MiniMed 740G Insulin Pump (O.U.S Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MiniMed 770G Insulin Pump (U.S Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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