Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item… Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedApr 15, 2020ClassClass 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform… Mixer blade may separate from mixer due to the screw and nut failure and detachment. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington and Wisconsin named
- Medical device recall The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a… The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone… Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Hawaii and Texas named
- Medical device recall LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a… A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Beckman Coulter MicroScan PROMPT Inoculation System-D Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, North Carolina, North Dakota, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Wisconsin, West Virginia and Wyoming named
- Medical device recall aap Implantate AG, Soft tissue retractor, radiolucent The company has become aware that the soft tissue retractor is not always removed during the sawing process. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic… Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereAlabama and New York
- Medical device recall ARTISTE MV System Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall MEVATRON M2/Primus Mid-Energy Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus… Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement Report12 statesnamed in where it went PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Florida, Georgia, Illinois, New York, Pennsylvania, Texas, Utah and Washington
- Medical device recall McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a… The firm received reports of a number of broken latches on the floorsitter. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedApr 15, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH,… Analyzer’s barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of… The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of… The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries… The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall “HEMOGLOBIN A1c CALIBRATORS *** Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile Sterility compromised due to packaging pouches that may not be sealed properly Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, New Jersey, New York, Ohio, Tennessee and Virginia named
- Medical device recall KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. Class IIFDA’s classApr 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre 5F Plus Over the Wire Embolectomy Catheter There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2020ClassClass IStatusOngoingWhereNationwide
- Medical device recall Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation… Distributed without an approved 510(k) Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI Distributed without an approved 510(k) Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Berchtold Chromophare Ceiling Mounted Surgical Light System The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical… Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Avalon Elite Vascular Access Kit A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled… Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report18 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Michigan, North Carolina, New Hampshire, New Mexico, New York, Ohio, Oklahoma, Tennessee, Texas and Virginia
- Medical device recall DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereArizona, California, Florida and Virginia
- Medical device recall Instructions for Use and Surgical Cleaning and Sterilization Protocol for Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Instructions for Use and Surgical Cleaning and Sterilization Protocol for Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar… Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco… Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock… Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step… Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe… Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Instructions for Use and Surgical Cleaning and Sterilization Protocol for Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock… Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint… Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary,… Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Expression MR400 MRI Patient Monitoring System Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1 Software defect in TEG Manager impacts the displayed alert for out of range test results. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Karl Storz SE & Co The firm has become aware that there is a potential that the glass cover at the distal end of the camera/led lighting on the video laryngoscope could become… Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall C-Reactive Protein Kit for use on the SPAplus A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportFloridathe one state its words name PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser… Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser… Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedApr 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Philips V60 Ventilators with Power Management PCBA Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual… Class IIFDA’s classApr 8, 2020in FDA’s Enforcement Report53 statesnamed in where it went PublishedApr 8, 2020ClassClass IIStatusOngoingWhereAlaska, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Gentell Hydrogel Ag 2x2 During an FDA audit, it was discovered that the product was not properly registered with FDA. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 8, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Iowa, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas and Wisconsin named
- Medical device recall Gentell Hydrogel Ag 4x4 During an FDA audit, it was discovered that the product was not properly registered with FDA. Class IIFDA’s classApr 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 8, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Iowa, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas and Wisconsin 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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