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 6, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or… Possible false negative or false positive results due to the product being compromised during shipment. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall VIDAS¿ CMV IgM 30 Tests bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01). Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, New Jersey, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Evolve Cell Culture Bags It was identified that tissue culture bags were incorrectly labeled as free of phthalates. Class IIIFDA’s classApr 21, 2021in FDA’s Enforcement Report19 statesnamed in where it went PublishedApr 21, 2021ClassClass IIIStatusTerminatedWhereCalifornia, Connecticut, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee and Texas
- Medical device recall Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior… Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 21, 2021ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall Covidien Surgiwand” II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22… Investigations related to customer complaints received for particulate matter inside of the Surgiwand” II device tubing components identified the root cause as… Class IIFDA’s classApr 21, 2021in FDA’s Enforcement Report36 statesnamed in where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Washington, Wisconsin and West Virginia
- Medical device recall ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result Class IIFDA’s classApr 21, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereCalifornia, Louisiana, Minnesota, North Carolina, Utah and Wisconsin
- Medical device recall cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on… Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under… Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under… Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at… Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP… Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Minnesota and Ohio named
- Medical device recall BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic… BioGX SARS-CoV-2 Reagents for BD MAX” System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL -… Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and New Jersey named
- Medical device recall Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Florida, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, New Jersey, New York, Oregon, Pennsylvania and Texas
- Medical device recall Disposable Sampling Tube Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing Class IIFDA’s classApr 21, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Louisiana and Texas
- Medical device recall Dasky Disposable Sampling Tube Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing Class IIFDA’s classApr 21, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Louisiana and Texas
- Medical device recall Dasky Disposable Sampling Tube Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing Class IIFDA’s classApr 21, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Louisiana and Texas
- Medical device recall Dasky Disposable Sampling Tube Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing Class IIFDA’s classApr 21, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Louisiana and Texas
- Medical device recall Remel Haemophilus Test Medium When tested with H. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Remel Haemophilus Test Medium(100mm) 10/PK When tested with H. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A… Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide, and Tennessee named
- Medical device recall Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01)… Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Illinois, Massachusetts, Michigan, Mississippi, North Carolina, Nevada, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall MAMBA Flex 135 Microcatheter The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, Colorado, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Virginia, Washington and Wisconsin named
- Medical device recall MAMBA Microcatheter The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, Colorado, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Virginia, Washington and Wisconsin named
- Medical device recall Alaris Infusion Pump Module Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 14, 2021in FDA’s Enforcement Report16 statesnamed in where it went PublishedApr 14, 2021ClassClass IStatusTerminatedWhereArizona, California, Delaware, Florida, Kentucky, Louisiana, Maine, Minnesota, Missouri, North Carolina, Nevada, New York, Pennsylvania, Tennessee, Texas and Washington
- Medical device recall Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 14, 2021in FDA’s Enforcement Report16 statesnamed in where it went PublishedApr 14, 2021ClassClass IStatusTerminatedWhereArizona, California, Delaware, Florida, Kentucky, Louisiana, Maine, Minnesota, Missouri, North Carolina, Nevada, New York, Pennsylvania, Tennessee, Texas and Washington
- Medical device recall Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB,… There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall Power Supply: 1 There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall Medtronic HVAD Alarm Adapter, Product Number: 1450 There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall Medtronic HVAD Monitor Data Cable, Product Number: 1575 There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall Medtronic HVAD There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood… Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols… Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas and Utah named
- Medical device recall Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear… Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols… Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas and Utah named
- Medical device recall Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and… Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols… Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas and Utah named
- Medical device recall Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the… A patient image was assigned to a different patient during image recovery process. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Minnesota, Ohio, Pennsylvania and Texas named
- Medical device recall Enteral Infusion Pump The potential for air appearing in the enteral feed pumping set tubing during set-up. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 14, 2021ClassClass IIStatusCompletedWhereNationwide, and District of Columbia named
- Medical device recall Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based… The wrong patient information may be displayed in the viewer or PowerJacket. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary… Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals… Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus… Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals… Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals… Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the… Contact lenses may be mislabeled with the incorrect lens power. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereNationwide, and Illinois and Missouri named
- Medical device recall Drop Arm Versamode” The front casters on the 6810A Lumex Drop Arm Versamode are incorrect. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Pennsylvania, Texas and Wisconsin named
- Medical device recall CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes… Incorrect labeling, Catheter did not have the required holes and markings Class IIFDA’s classApr 14, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Kentucky, Maryland, North Carolina, New York, Texas and Wisconsin
- Medical device recall At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924,… Device was distributed without a proper marketing authorization. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903) Device was distributed without a proper marketing authorization. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870) Device was distributed without a proper marketing authorization. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Deluxe At Home Pro Series Insemination Kit (SKU 644042787958) Device was distributed without a proper marketing authorization. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Deluxe At Home Artificial Insemination Kit (SKU 636391205832) Device was distributed without a proper marketing authorization. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Premium At Home Pro Series Insemination Kit (SKU 644042787927) Device was distributed without a proper marketing authorization. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNo state named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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