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 Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For… Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare… Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 31, 2021ClassClass IIStatusOngoingWhereNationwide, and Tennessee named
- Medical device recall Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor,… Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous… This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm,… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Tennessee named
- Medical device recall CAIRE DIAGNOSTICS FenomPro Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Texas and Wisconsin named
- Medical device recall Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3 There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 31, 2021ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3 There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 31, 2021ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3 There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 31, 2021ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging… Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky, Michigan and Texas named
- Medical device recall BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement Report52 statesnamed in where it went PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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 Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light… Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope,… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 31, 2021ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall RUSCH¿ POLARIS” Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal… Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only) Potential total iron-binding capacity (TIBC) results. Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Operating Table System There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement Report41 statesnamed in where it went PublishedMar 31, 2021ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, 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 S-Series Equipment Management System The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMar 31, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION) Teleflex is recalling this product due to a lack of assurance of sterility. Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Illinois, New Jersey, New York, Pennsylvania and Tennessee named
- Medical device recall The ImmunoCard Mycoplasma EIA detects the presence of IgM to M Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Ohio and South Carolina named
- Medical device recall In-View Clear Leggings Sterile Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick ,… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall In-View Clear Leggings Sterile Non-Sterile Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick ,… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall In-View Clear Leggings Bulk Non-Sterile Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick ,… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Femoral Angiography Drape Sterile Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick ,… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Femoral Angiography Drape Bulk Non-Sterile Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick ,… Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall VITEK 2 (version numbers 8.01, 8.02 bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VITEK 2 Compact (version numbers 8.01, 8.02 bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface… Products being recalled due to potentially elevated level of bacterial endotoxin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance… Products being recalled due to potentially elevated level of bacterial endotoxin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR) Products being recalled due to potentially elevated level of bacterial endotoxin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B) Products being recalled due to potentially elevated level of bacterial endotoxin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B) Products being recalled due to potentially elevated level of bacterial endotoxin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO) Products being recalled due to potentially elevated level of bacterial endotoxin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR) Products being recalled due to potentially elevated level of bacterial endotoxin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B) Products being recalled due to potentially elevated level of bacterial endotoxin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B) Products being recalled due to potentially elevated level of bacterial endotoxin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON) Products being recalled due to potentially elevated level of bacterial endotoxin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI Product was compromised during shipment. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Kentucky, Ohio and Pennsylvania named
- Medical device recall Magellan Hypodermic Safety Needle, 25 G x 5/8” Safety shield not locking into the cannula. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8” Safety shield not locking into the cannula. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8” Safety shield not locking into the cannula. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows:… SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and… Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mindray BeneVision BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)) R&D Systems, Inc. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereCalifornia, Florida, Louisiana and Ohio
- Medical device recall JUDKINS PACK Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect… Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereVirginia
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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