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 IceRod” 1.5 PLUS 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 PLUS 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 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 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 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 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 S 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 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 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 IceSeed” 1.5 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 IceSeed” 1.5 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 IceEDGE” 2.4¿ 90p¿ 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 MRI 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 MRI 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 IceSeed” 1.5¿ MRI 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 IceSeed” 1.5 MRI 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 Prostate Cryoablation Kit 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 Prostate Cryoablation Kit 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 Three IceFORCE” 2.1 CX Prostate Cryoablation Kit 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 Three IcePearl” 2.1 CX Prostate Cryoablation Kit 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” i-Thaw” Prostate Cryoablation Kit 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 IceSeed” Prostate Cryoablation Kit 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” Prostate Cryoablation Kit 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 Five IceSphere” Prostate Cryoablation Kit 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 Five IceRod” i-Thaw” Prostate Cryoablation Kit 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” i-Thaw” Prostate Cryoablation Kit 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 IceSeed” Prostate Cryoablation Kit 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” He-Thaw Prostate Cryoablation Kit 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 Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed… A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida and Texas named
- Medical device recall Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and… A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida and Texas named
- Medical device recall Spinal Rod Cutter Device has the potential for fracture during use. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with… Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that… Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, and Oklahoma named
- Medical device recall AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label. Class IIIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 30, 2020ClassClass IIIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, Massachusetts, Missouri, Pennsylvania, Texas and Virginia named
- Medical device recall 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31” (79 cm) Admin Set w/20 Drop… Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, 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 Spinning Spiros, Closed Male Luer Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, 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 5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75” (191 cm) Appx 9.1 ml, 20 Drop Admin… Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, 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 30” (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF:… Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, 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 30” (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger,… Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, 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 3mL Syringe w/Spinning Spiros, Red Cap Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, 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 30” (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag… Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, 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 Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, 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 31” (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF:… Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, 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 76 cm (30”) Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag… Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, 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 Spinning Spiros Closed Male Luer, Red Cap Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, 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 Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, 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 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide, 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 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used… There is a potential software error during programming. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used… There is a potential software error during programming. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide
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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