Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, 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.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Naturalyte Liquid Acid concentrate bottles The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Citrasate Liquid Acid concentrate bottles The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Naturalyte Liquid Acid concentrate bottles The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Naturalyte Liquid Acid concentrate bottles The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Naturalyte Liquid Acid concentrate bottles The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Naturalyte Liquid Acid concentrate bottles The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Naturalyte Liquid Acid concentrate drums The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Naturalyte Liquid Acid concentrate drums The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Citrasate Liquid Acid concentrate drums The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD Labeling update; To reduce the risk of false positive/false negative results the IFU for the adaptive immune response to SRS-CoV-2 testing is being updated to… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Maryland, Missouri, North Carolina, New York, Oklahoma, Oregon and Texas named
- Medical device recall CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management… Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using… Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein… Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification… Dirty Lens May Cause Invalid or False Positive Results Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 -… Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Georgia, Maryland, Minnesota, Montana, Virginia and Washington named
- Medical device recall Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear… A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE NM/CT 850 system GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GE NM/CT 860 system GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GE NM/CT 870 CZT system GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number… GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB),… GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Optima NM/CT 640 GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall icumedical Cogent” Hemodynamic Monitoring System - Product Usage: intended for patients for whom the… Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Illinois, Kentucky, Maryland, Maine, Michigan, North Carolina, New Jersey, Ohio, Pennsylvania, Tennessee, Texas, Vermont, Washington and Wisconsin named
- Medical device recall Medtronic Intellis Spinal Cord Stimulator A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall All EPIQ and Affiniti Ultrasound systems The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJan 20, 2021ClassClass 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, 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 Eleganza 5 (AC powered adjustable bed) A component used within the side rail mechanism may malfunction, resulting in the side rail either not locking properly in the upper position or the side rail… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MiniCap Extended Life PD Transfer Set Potential for no-flow and leaks under the twist clamp. Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Chemistry Products CKMB Slides VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Bone fixation nail Manufacturing packaging error. Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Iowa, Kentucky, Michigan, North Carolina, New Jersey, Ohio, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The… The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The… The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The… The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product… The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product… The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product… The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in… The cylindrical sponge component is not x-ray detectable. Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Simple Neck Dissection The cylindrical sponge component is not x-ray detectable. Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Thyroid Pack CKHA-LF The cylindrical sponge component is not x-ray detectable. Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Greffe Aorte-LF (product info is in French) The cylindrical sponge component is not x-ray detectable. Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Cardiac Pack - LF The cylindrical sponge component is not x-ray detectable. Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise… “MLC tickle error” may result in the delivered dose to effectively rotate from the planned dose. Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, North Dakota, New Jersey, Oklahoma and Utah named
- Medical device recall TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the… “MLC tickle error” may result in the delivered dose to effectively rotate from the planned dose. Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, North Dakota, New Jersey, Oklahoma and Utah named
- Medical device recall Vis-U-All High Temperature Tubing 3”x100’ Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temperature Tubing 4”x100’ Purple ink located on the outside label of Vis-U-All Pouches may migrate (bleed) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temperature Tubing 6”x100’ Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
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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