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 ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alinity s System A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Spectrum Medical Quantum Standard heat exchanger Product labeled as sterile may not have been adequately sterilized. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and South Carolina named
- Medical device recall Edwards PediaSat Oximetry Catheter Kit There is a potential for internal leaks within catheters. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, Texas and Washington
- Medical device recall Edwards PediaSat Oximetry Catheter Kit There is a potential for internal leaks within catheters. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, Texas and Washington
- Medical device recall Edwards PediaSat Oximetry Catheter Kit There is a potential for internal leaks within catheters. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, Texas and Washington
- Medical device recall Edwards PediaSat Oximetry Catheter Set There is a potential for internal leaks within catheters. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, Texas and Washington
- Medical device recall Edwards PediaSat Oximetry Catheter Set There is a potential for internal leaks within catheters. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, Texas and Washington
- Medical device recall Edwards PediaSat Oximetry Catheter Set There is a potential for internal leaks within catheters. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, Texas and Washington
- Medical device recall Regard NEWBORN KIT, LD00201j Instructions for use updated to include the following cautionary statement for the heel warmer, “Activate away from the user’s face and away from the infant… Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportMissourithe one state its words name PublishedAug 11, 2021ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Regard NEWBORN KIT, LD00201K Instructions for use updated to include the following cautionary statement for the heel warmer, “Activate away from the user’s face and away from the infant… Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportMissourithe one state its words name PublishedAug 11, 2021ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Regard NEWBORN KIT, LD00201M Instructions for use updated to include the following cautionary statement for the heel warmer, “Activate away from the user’s face and away from the infant… Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportMissourithe one state its words name PublishedAug 11, 2021ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast The devices have a different inner diameter than the diameter specified on the outer box label. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast The devices have a different inner diameter than the diameter specified on the outer box label. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GlideScope Go Monitors Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality. Class IIIFDA’s classAug 11, 2021in FDA’s Enforcement Report53 statesnamed in where it went PublishedAug 11, 2021ClassClass IIIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Sharesource Connectivity Platform for Use with the Amia Automated PD System Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes… Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 11, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kaguya Automated Peritoneal Dialysis System Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes… Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 11, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flex IUI Set with LED Lighted Speculum and Test kit Device was distributed without a proper marketing authorization. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests Device was distributed without a proper marketing authorization. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum Device was distributed without a proper marketing authorization. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium Device was distributed without a proper marketing authorization. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 2 X Sterile Human Home Artificial Insemination Semen Kit (Human) Device was distributed without a proper marketing authorization. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits Device was distributed without a proper marketing authorization. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests Device was distributed without a proper marketing authorization. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Deluxe IntraCervical Insemination (ICI) Kit Device was distributed without a proper marketing authorization. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds Device was distributed without a proper marketing authorization. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine… There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Idaho, Maine, New York, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Idaho, Maine, New York, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Idaho, Maine, New York, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Idaho, Maine, New York, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401 Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot… Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 11, 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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