Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Alaris PCA Module Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2020ClassClass IStatusTerminatedWhereNationwide, and American Samoa, Guam and Puerto Rico named
- Medical device recall Alaris EtCO2 Module Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2020ClassClass IStatusTerminatedWhereNationwide, and American Samoa, Guam and Puerto Rico named
- Medical device recall Alaris SpO2 Module Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2020ClassClass IStatusTerminatedWhereNationwide, and American Samoa, Guam and Puerto Rico named
- Medical device recall Alaris Auto ID Module Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2020ClassClass IStatusTerminatedWhereNationwide, and American Samoa, Guam and Puerto Rico named
- Medical device recall Medfusion Syringe Pump Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 12, 2020ClassClass IStatusOngoingWhereNo state named
- Medical device recall Medfusion Syringe Pump Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 12, 2020ClassClass IStatusOngoingWhereNo state named
- Medical device recall Alaris Pump Module Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2020in FDA’s Enforcement Report54 statesnamed in where it went PublishedAug 12, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, American Samoa, 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, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Alaris System PC Unit If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2020in FDA’s Enforcement Report55 statesnamed in where it went PublishedAug 12, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, American Samoa, 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, Northern Mariana Islands, 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 Alaris System PC Unit If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2020in FDA’s Enforcement Report55 statesnamed in where it went PublishedAug 12, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, American Samoa, 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, Northern Mariana Islands, 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 Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and… Results from repeated run for WBC (White Bloodcell Count), UWBC (Urine Whit Bloodcell Count) and PLT (Platelets) are deleted in RADV. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, Indiana, Kansas, Michigan, Missouri, North Carolina, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Virginia and West Virginia named
- Medical device recall Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is… Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Indiana, Kansas, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Oklahoma, South Carolina, Texas and Washington named
- Medical device recall Mako Hip End Effector, Variable Angle Characterization issue associated with the product. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, New York, Rhode Island, Tennessee and Texas
- Medical device recall SUTUREFIX ULTRA Suture, Product number 72203855 A packaging error resulted in a XL drill being presented for use instead of the S drill. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement Report23 statesnamed in where it went PublishedAug 12, 2020ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, Colorado, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall DCA Vantage Handheld Barcode Scanner - Zebra If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pleur-Evac Adult-Ped Wet, LF Intl Eng Potential for sterile packaging to be compromised¿ Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida and Puerto Rico named
- Medical device recall Pleur-Evac Adult-Ped Wet, LF Eng/Spanish Potential for sterile packaging to be compromised¿ Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida and Puerto Rico named
- Medical device recall CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient… CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a… Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Montana, North Carolina, Texas and Wisconsin named
- Medical device recall Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended… Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and West Virginia named
- Medical device recall Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended… Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and West Virginia named
- Medical device recall Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device… Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and West Virginia named
- Medical device recall BD MAX SARS-CoV-2 Reagents BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Guam, Hawaii, Illinois, Indiana, Kentucky, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Texas, Wisconsin and Wyoming named
- Medical device recall SIEMENS Healthineers Luminos dRF Max Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max… Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIEMENS Healthineers Luminos Agile Max Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max… Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIEMENS Healthineers Uroskop Omnia max Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max… Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max… Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which… BSC has noted a potential inability to cut and remove polyps for these lots/batches. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 12, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which… BSC has noted a potential inability to cut and remove polyps for these lots/batches. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 12, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which… BSC has noted a potential inability to cut and remove polyps for these lots/batches. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 12, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which… BSC has noted a potential inability to cut and remove polyps for these lots/batches. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 12, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which… BSC has noted a potential inability to cut and remove polyps for these lots/batches. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 12, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be… BSC has noted a potential inability to cut and remove polyps for these lots/batches. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 12, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which… BSC has noted a potential inability to cut and remove polyps for these lots/batches. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 12, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to… Potential risk of brush detachment during cleaning. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Indiana and Ohio named
- Medical device recall BOSS DeBakey “Gator-Grip” Needle Holder 2 mm tip, 9” The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Tennessee and Texas named
- Medical device recall Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device… This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 12, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device… This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. Class IIFDA’s classAug 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 12, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and… One lot of MatrixNEURO 5mm screws was packaged in a body clip etched “4”, which indicated a 4mm screw. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The… The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the “accept” window at the time of use. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Missouri, North Carolina and Oklahoma named
- Medical device recall InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product… A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alinity ci series System Control Module (SCM) Quality Control results were not properly evaluated for QC failures. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of… Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 5, 2020ClassClass IIStatusOngoingWhereNationwide, and Colorado named
- Medical device recall Computed Tomography X-ray System The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 5, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Indiana and Texas named
- Medical device recall Computed Tomography X-ray System The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 5, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Indiana and Texas named
- Medical device recall Computed Tomography X-ray System The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 5, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Indiana and Texas named
- Medical device recall Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the… Tube material of a smaller diameter was used. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall StealthStation” S7 System with Polaris Spectra Camera There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while… Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama and Massachusetts named
- Medical device recall TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses Colored contact lenses were distributed without FDA clearance. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses Colored contact lenses were distributed without FDA clearance. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2020ClassClass 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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