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 Edwards TruWave There is a potential that the pressure tubing may detach from the blood sampling system Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Puerto Rico, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers… The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts and South Carolina
- Medical device recall SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane… The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts and South Carolina
- Medical device recall Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200… The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts and South Carolina
- Medical device recall SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane… The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts and South Carolina
- Medical device recall Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts and South Carolina
- Medical device recall PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft Due to external labelling error/mix-up. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Massachusetts and North Carolina named
- Medical device recall Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT The HAT trial contains a retaining ring that has shown the potential to disengage during use. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 7, 2021ClassClass IIStatusCompletedWhereNationwide, and Arizona, Colorado, Florida, New York, South Carolina and Tennessee named
- Medical device recall NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and… Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and… Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and… Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and… Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and… Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128,… Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon… Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 -… Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand… Catheter kits contained the incorrect micro-introducers. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Massachusetts, Michigan, Montana, New Jersey, Nevada, New York, Virginia and Wisconsin
- Medical device recall PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Maryland, Michigan and Pennsylvania named
- Medical device recall 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC Catheter convenience kits contain the incorrect guidewire. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereNationwide, and Rhode Island named
- Medical device recall MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector… A portion of a validation lot was inadvertently released to the US Market. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall Physician Order Form (PL-15400-00, Nov. 2018) Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text ‘Refill the pump and program refill with the same medication removed… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Kansas, Maryland, Minnesota, Montana, New York, Pennsylvania, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 30, 2021ClassClass IStatusTerminatedWhereNationwide, and Florida, Georgia, Kansas, Louisiana, Maryland, Minnesota, North Carolina, Texas and Virginia named
- Medical device recall Sapi Med sterile disposable colorectal anoscopes and proctoscopes Due to issue with product sterility. Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Illinois, Massachusetts and Pennsylvania
- Medical device recall Ventec Life Systems VOCSN Multi-Function Ventilator Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 30, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BioFire BCID2 Panel Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028,… Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereAlabama, Arizona, Florida, Georgia, Illinois, Massachusetts, Missouri, New Jersey, Oregon and Virginia
- Medical device recall Access SARS CoV-2 lgG II Reagent SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report31 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall Access SARS-CoV-2 lgG II Calibrator SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file… Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report31 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall Probe Cover 6” x 48” regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID:… No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall Probe Cover 6” x 96” regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall 6” x 48” Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall 6” x 96” Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU-… No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall Probe Cover, 6”x96” poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall 6” x 48” Elastic Poly Probe Cover, Tele Fold, sq No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall Probe Cover, Lite poly, 6”x48”, w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall Probe Cover Elastic Poly 6” x 48”- Ultrasonic Transducer Cover Item ID: E5322N No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359 No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360 No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall Probe Cover, 6” x 96”, PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall Hays Ultrasound kit Item ID: H1000SE No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
- Medical device recall Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL No 510k for the product to be used in a natural or surgical opening to the body Class IIFDA’s classJun 30, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Montana, New York, Ohio and Puerto Rico
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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