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 Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive… Shipping box may contain wrong model. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and West Virginia named
- Medical device recall ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Texas, Washington and West Virginia named
- Medical device recall Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and… The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction, potentially leading… Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001 When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the… Class IIFDA’s classJan 27, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereMaryland and Michigan
- Medical device recall Synapse PACS Software Versions 5.1 and higher There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EMBLEM S-ICD Subcutaneous Electrode There is potential for fractures which results in the inability to delivery therapy. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 27, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 27, 2021ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized… Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for… Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Abbott i-STAT EG7+ cartridge-IVD Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for… Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for… The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and… A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Equinoxe Humeral Stem, Primary, Press Fit, 11mm Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 27, 2021ClassClass IIStatusOngoingWhereCalifornia, Kansas and Ohio
- Medical device recall Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno When the user changes frame rates from lower frequency (e.g. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 20, 2021in FDA’s Enforcement Report38 statesnamed in where it went PublishedJan 20, 2021ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 20, 2021in FDA’s Enforcement Report38 statesnamed in where it went PublishedJan 20, 2021ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 20, 2021in FDA’s Enforcement Report38 statesnamed in where it went PublishedJan 20, 2021ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 20, 2021in FDA’s Enforcement Report38 statesnamed in where it went PublishedJan 20, 2021ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 20, 2021in FDA’s Enforcement Report38 statesnamed in where it went PublishedJan 20, 2021ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 20, 2021in FDA’s Enforcement Report38 statesnamed in where it went PublishedJan 20, 2021ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Remel Blood Agar/MacConkey Agar Bi-Plate The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, Louisiana, Mississippi, North Carolina, South Carolina and Tennessee
- Medical device recall SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Uroskop Omnia After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor… 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 Uroskop Omnia Max After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor… 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 VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding… VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Massachusetts, Mississippi, Ohio, Oregon, Texas, Virginia, Washington and West Virginia named
- Medical device recall Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25 One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -3.75 contact lenses Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Disposable Humidification Flask, Reference A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EXOGEN Ultrasound Coupling Gel Product may contain white particulates that are microbial in nature. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NaturaLyte Liquid Acid concentrate bottles The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to… STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Delaware, Florida, Iowa, Massachusetts, Ohio, Pennsylvania, Texas, Virginia and Washington named
- 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
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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