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 VITROS Immunodiagnostic Products Prolactin Reagent Pack Falsely high or delayed patient and QC results may occur due to low end imprecision. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for… Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Olympus Uretero-reno videoscope The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona named
- Medical device recall CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE The device was not cleared for U.S. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 25, 2022ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Accula SARS-CoV-2 Test SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 18, 2022ClassClass IStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, North Dakota, New Jersey, New York, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray Product was sterilized with a higher than specification EO concentration. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide, and Illinois, Missouri, Nebraska and Texas named
- Medical device recall 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack Product was sterilized with a higher than specification EO concentration. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide, and Illinois, Missouri, Nebraska and Texas named
- Medical device recall ACS IR - Angio Pack Product was sterilized with a higher than specification EO concentration. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide, and Illinois, Missouri, Nebraska and Texas named
- Medical device recall ACS Lap Chole Pack Product was sterilized with a higher than specification EO concentration. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide, and Illinois, Missouri, Nebraska and Texas named
- Medical device recall ACS Cath Lab Pack Product was sterilized with a higher than specification EO concentration. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide, and Illinois, Missouri, Nebraska and Texas named
- Medical device recall Philips Hemodynamic Application When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 18, 2022ClassClass IIStatusTerminatedWhereFlorida, Idaho, New Jersey, Oklahoma, South Carolina and Texas
- Medical device recall Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO Packaging for Balloon Catheters may be damaged resulting in loss of sterility. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedMay 18, 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, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter Packaging for Balloon Catheters may be damaged resulting in loss of sterility. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedMay 18, 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, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 18, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 18, 2022ClassClass IStatusOngoingWhereAlabama and Georgia
- Medical device recall Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 18, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 18, 2022ClassClass IStatusOngoingWhereAlabama and Georgia
- Medical device recall BF-MP60: OES Bronchofiberscope Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after… Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BF-3C160: EVIS EXERA Bronchovideoscope Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after… Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BF-MP160F: EVIS EXERA Bronchofibervideoscope Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after… Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BF-1TQ180: EVIS EXERA II Bronchovideoscope Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after… Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Diagnostic Kit SARS-cCo V Antigen Rapid Test COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Indiana, Maryland, Missouri, New Jersey, Oklahoma and Tennessee named
- Medical device recall Regard brand CABG Pack A and B - Spartanburg Kits were packed into shipping boxes incorrectly. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 18, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall HemosIL ReadiPlasTin Variable and out of specification QC results with HemosIL ReadiPlasTin. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Iowa, Illinois, Indiana, Kansas, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, South Carolina, Texas, Virginia and West Virginia named
- Medical device recall STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1 Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, New Hampshire, New Jersey, Oklahoma, South Carolina, Texas and Washington named
- Medical device recall 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, New Hampshire, New Jersey, Oklahoma, South Carolina, Texas and Washington named
- Medical device recall putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe Patient chart label contains incorrect Part Number and volume amount. Class IIIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMay 18, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, District of Columbia, Delaware, Idaho, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, 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 ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives… Class IIFDA’s classMay 18, 2022in FDA’s Enforcement Report12 statesnamed in where it went PublishedMay 18, 2022ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Iowa, Massachusetts, Missouri, New Hampshire, New York, Ohio, Oklahoma, Texas and Virginia
- Medical device recall VITEK 2 Systems and VITEK 2 with MYLA. Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected… Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNorth Carolina
- Medical device recall The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2… First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement Report36 statesnamed in where it went PublishedMay 18, 2022ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CYSTO-URETHRO-FIBERSCOPE Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 18, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 18, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 18, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 18, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 18, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 18, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 18, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 11278V 11278VK CMOS Video Ureteroscope Z17744US-A Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 18, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 18, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 18, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall TMJ Arthroscopy Drape, 85’’x 96’’ Latex content in product was labeled incorrectly as latex free. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 18, 2022ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Pennsylvania and Wisconsin named
- Medical device recall Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection,… Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 1 Series CX phototherapy units equipped with Daavlin’s ClearLink Control System software versions v3.03h and… Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0” inches to “9. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall 4 Series CX phototherapy units equipped with Daavlin’s ClearLink Control System software versions v3.03h and… Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0” inches to “9. Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 18, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Digital Medical X-ray Imaging System X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be… Class IIFDA’s classMay 18, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 18, 2022ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall Azurion systems with software release R1.x In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) The product was distributed without FDA authorization or clearance for marketing and distribution in the US. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 11, 2022ClassClass IStatusOngoingWhereNationwide, and Alabama, Florida, Georgia, Missouri, New York, Texas and Wyoming named
- Medical device recall BD Synapsys Microbiology Informatics Solution When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic… Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 11, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Michigan, New York, Ohio, South Carolina and Tennessee named
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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