Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, 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.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made Distributed VTM outside of VTM Guidance and without clearance. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 17, 2022ClassClass IStatusOngoingWhereNationwide, and California, Florida, Illinois and New York named
- Medical device recall Cobalt Implantable Cardioverter Defibrillators: a There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 17, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 17, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 17, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 17, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Cobalt Implantable Cardioverter Defibrillators: a There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 17, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 17, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 17, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 17, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Crome Implantable Cardioverter Defibrillators: a There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 17, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 17, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 17, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 17, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per… Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 17, 2022ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per… Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 17, 2022ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total… Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin,… Class IIFDA’s classAug 17, 2022in FDA’s Enforcement Report28 statesnamed in where it went PublishedAug 17, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 17, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, Oklahoma and Texas named
- Medical device recall 3D Systems VSP Reconstruction Scapula Marking Guide (anatomically Shaped) was incorrectly designed. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 17, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000,… As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service… Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 17, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Xhibit Telemetry Receiver Software related alarm escalation defect occurs after approximately 25 days of continuous use. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedAug 17, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia and Washington named
- Medical device recall ShockPulse-SE Lithotripsy Generator Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 17, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama and New Mexico named
- Medical device recall cobas e801 Immunoassay Analyzer Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 17, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010 Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereArkansas, Indiana, North Carolina and Nebraska
- Medical device recall SARS CoV 2 rapid antigen test kits Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 10, 2022ClassClass IStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Louisiana, Maryland, Nevada, New York, Ohio and Pennsylvania named
- Medical device recall NanoSight NS300 Product found to not comply to Class 1 Laser safety requirement. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 10, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH Endoscopic graspers may become separated at the weld from handle to the shaft of the device. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedAug 10, 2022ClassClass IIStatusCompletedWhereNationwide, and Alaska, 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, North Carolina, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH Endoscopic graspers may become separated at the weld from handle to the shaft of the device. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedAug 10, 2022ClassClass IIStatusCompletedWhereNationwide, and Alaska, 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, North Carolina, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Medline Sprinter OTW Luer has balloon diameter printed as “2.25mmx12mm” instead of the correct diameter, “2.5mmx12mm” as reflected on the product outer packaging. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 10, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da… Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi… Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedAug 10, 2022ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is Product may be mislabeled. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement Report10 statesnamed in where it went PublishedAug 10, 2022ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Georgia, Iowa, Illinois, Indiana, New York, Ohio, Texas and Wyoming
- Medical device recall EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is Product may be mislabeled. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement Report10 statesnamed in where it went PublishedAug 10, 2022ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Georgia, Iowa, Illinois, Indiana, New York, Ohio, Texas and Wyoming
- Medical device recall MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES stability failure Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 10, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CustMbite, Model Number CBT-SRS-UL The device was marketed and sold in the US without FDA clearance. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 10, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Merlin PCS 3650 programmer There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery… Class IIFDA’s classAug 10, 2022in FDA’s Enforcement Report54 statesnamed in where it went PublishedAug 10, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, 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, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Merlin 2 PCS MER37000 programmer The Merlin” 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical… Class IIFDA’s classAug 10, 2022in FDA’s Enforcement Report54 statesnamed in where it went PublishedAug 10, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, 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, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Merlin.net model MN5000 Software The Merlin” 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical… Class IIFDA’s classAug 10, 2022in FDA’s Enforcement Report54 statesnamed in where it went PublishedAug 10, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, 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, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human… Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 10, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Craftmatic Model 1 Base for Dual Bed Configurations A potential for dual-configured beds to separate or slip away from one another. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 10, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Legacy Base for Dual Bed Configurations A potential for dual-configured beds to separate or slip away from one another. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 10, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Turbett Surgical Container, TS1500 Devices were subject to unapproved rework processes. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 10, 2022ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, North Carolina and Pennsylvania named
- Medical device recall UroLift System There is the potential that during implant deployment, the device may not properly deliver a implant. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 10, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia
- Medical device recall ABACUS TPN (Total Parenteral Nutrition) Calculation software There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 3, 2022in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 3, 2022ClassClass IStatusTerminatedWherePuerto Rico
- Medical device recall CereLink ICP Monitor Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message “sensor or extension cable… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 3, 2022ClassClass IStatusOngoingWhereNationwide, and Georgia named
- Medical device recall Intraosseous needle and driver BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall Description/Part: Simplify Disc Size 1, Ht 5/SM-5 Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and… Class IIFDA’s classAug 3, 2022in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereCalifornia, Florida, Indiana, Michigan, Missouri, Oregon, Texas, Virginia and Washington
- Medical device recall REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement Report43 statesnamed in where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement Report43 statesnamed in where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement Report43 statesnamed in where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No.… The device may potentially cause a fire, leading to a safety risk. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Paragon 28, Inc Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Da Vinci S/Si Large Clip Applier Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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 named
- Medical device recall Da Vinci X/Xi Large Clip Applier Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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 named
- Medical device recall etouchus, model no. ETM-G01. Noninvasive Blood glucose meter. Device was marketed without FDA 510(k) clearance or a PMA. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 3, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall nordicBrainEX, software versions 2.21 through 2.3.10 When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset,… Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusTerminatedWhereNationwide
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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