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 5, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall CADD Administration Sets Product may have been manufactured with an air filter assembled in an incorrect orientation. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated… Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals… Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated… Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall smiths medical portex Loss of Resistance Device The labeling was missing information on sterilization and prohibition of reuse. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X… Due to misbranded products shipped to customers. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report16 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Hawaii, Illinois, Indiana, Louisiana, Missouri, Mississippi, North Carolina, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Washington
- Medical device recall Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4”Biopsy/Aspiration needle, sterile, Qty:… Due to misbranded products shipped to customers. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report16 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Hawaii, Illinois, Indiana, Louisiana, Missouri, Mississippi, North Carolina, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Washington
- Medical device recall medfusion Stopcock, 1-way and 4-way Product has a lack of sterility assurance Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT… There was an increase in complaints related to tip breaks and wobble/vibration. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT… There was an increase in complaints related to tip breaks and wobble/vibration. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT… There was an increase in complaints related to tip breaks and wobble/vibration. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R,… There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Illinois, Kansas, Massachusetts, Michigan, Missouri, North Carolina, New York, Oklahoma, Pennsylvania and Texas named
- Medical device recall REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R,… There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Illinois, Kansas, Massachusetts, Michigan, Missouri, North Carolina, New York, Oklahoma, Pennsylvania and Texas named
- Medical device recall Easi-Care Gait Belt Metal Buckle The belt may fail at lower loads than the labeled 600lbs. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement Report14 statesnamed in where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Kentucky, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Tennessee and Virginia
- Medical device recall SIMPLEXA COVID-19 Positive Control Pack Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 27, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application… There is a potential for false positive results. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application… There is a potential for false positive results. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File There is a potential for false positive results. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File There is a potential for false positive results. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File There is a potential for false positive results. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC… Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedOct 20, 2021ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia and Washington named
- Medical device recall ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedOct 20, 2021ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia and Washington named
- Medical device recall Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 20, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Philips, HeartStart FR2 + Defibrillator Customers were not notified of previous recalls associated with various defibrillator models. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement Report12 statesnamed in where it went PublishedOct 20, 2021ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Florida, Georgia, Indiana, Michigan, Missouri, New Jersey, New York, Ohio, Texas and Washington
- Medical device recall Philips, HeartStart FRx + Defibrillator Customers were not notified of previous recalls associated with various defibrillator models. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement Report12 statesnamed in where it went PublishedOct 20, 2021ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Florida, Georgia, Indiana, Michigan, Missouri, New Jersey, New York, Ohio, Texas and Washington
- Medical device recall Philips, HeartStart HS1 Home Defibrillator Customers were not notified of previous recalls associated with various defibrillator models. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement Report12 statesnamed in where it went PublishedOct 20, 2021ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Florida, Georgia, Indiana, Michigan, Missouri, New Jersey, New York, Ohio, Texas and Washington
- Medical device recall Philips, HeartStart HS1 OnSite Defibrillator Customers were not notified of previous recalls associated with various defibrillator models. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement Report12 statesnamed in where it went PublishedOct 20, 2021ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Florida, Georgia, Indiana, Michigan, Missouri, New Jersey, New York, Ohio, Texas and Washington
- Medical device recall BioPlex 2200 ANA Screen Control Set A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall cobas EGFR Mutation Test v2-Somatic gene mutation detection system False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System Under certain conditions, there is a risk for a false negative result. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endoskeleton” TAS Interbody System with Titan nanoLOCK” Surface Technology, Nanolock 12 Dg Interbody, Large,… Engraving on implants may not match what is listed on the pouch labels. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement Report14 statesnamed in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereCalifornia, Minnesota, Missouri, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Washington and West Virginia
- Medical device recall Endoskeleton” TCS Interbody System with Titan nanoLOCK” Surface Technology, NanoLock, 6 Deg, Interbody,… Engraving on implants may not match what is listed on the pouch labels. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement Report14 statesnamed in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereCalifornia, Minnesota, Missouri, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Washington and West Virginia
- Medical device recall FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.) The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall EcoGel 100 - RED Medical Supplies Green Ultrasound Gel Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall medex LogiCal 5mL Closed Blood Sampling System Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smiths medical medex CBSS 2-fach Druckmesset mit Option Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smiths medical medex CBSS-5ML Zweifach set Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smiths medical medex CBSS-5ML Antishunt set Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smiths medical medex CBSS-5ML, Triple set Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smiths medical medex CBSS-5ML, Single Set Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smiths medical medex CBSS-5ML, Double set Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNo 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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