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 INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L:… Class IIFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 29, 2022ClassClass IIStatusTerminatedWhereNationwide, and South Carolina named
- Medical device recall CardioTek EP-TRACER Software V2.x. Device did not pass electrical safety testing for adequate insulation. Class IIFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 29, 2022ClassClass IIStatusCompletedWhereNationwide, and California, North Carolina and New York named
- Medical device recall Drager SafeStar 55 Possible occlusion of filters due to manufacturing error. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJun 22, 2022ClassClass IStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, North Dakota, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington and West Virginia named
- Medical device recall t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 22, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model:… cybersecurity vulnerability Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJun 22, 2022ClassClass IIStatusCompletedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall illumina Model NextSeq 550 Dx REF 20005715 cybersecurity vulnerability Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJun 22, 2022ClassClass IIStatusCompletedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall AXIUM DETACHABLE COIL SYSTEM Due to incorrect size and configuration labeling of the detachable coil system. Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 22, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Olympus CYSTONEPHROFIBERSCOPE Incorrect adhesive used to secure the diopter ring and nameplate ring. Class IIFDA’s classJun 22, 2022in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 22, 2022ClassClass IIStatusOngoingWhereCalifornia, Florida, Massachusetts, Maryland, Michigan, New Jersey, Ohio, Puerto Rico and Wisconsin
- Medical device recall Olympus URETERO-RENO FIBERSCOPE Incorrect adhesive used to secure the diopter ring and nameplate ring. Class IIFDA’s classJun 22, 2022in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 22, 2022ClassClass IIStatusOngoingWhereCalifornia, Florida, Massachusetts, Maryland, Michigan, New Jersey, Ohio, Puerto Rico and Wisconsin
- Medical device recall Olympus URETERO-RENO FIBERSCOPE Incorrect adhesive used to secure the diopter ring and nameplate ring. Class IIFDA’s classJun 22, 2022in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 22, 2022ClassClass IIStatusOngoingWhereCalifornia, Florida, Massachusetts, Maryland, Michigan, New Jersey, Ohio, Puerto Rico and Wisconsin
- Medical device recall CARESCAPE Central Station (CSCS) V2 The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR:… Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy… Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJun 22, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR:… Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy… Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJun 22, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Philips OmniWire Pressure guide wire Due to a potential failed sterilization process. Class IIFDA’s classJun 22, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereWashington and Wisconsin
- Medical device recall HeartWare HVAD Pump Implant Kit, a) The pump may have a welding defect that can lead the pump to malfunction. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 15, 2022ClassClass IStatusOngoingWhereNationwide, and Delaware and Texas named
- Medical device recall Back up batteries in Ventilators labeled as the following: a Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJun 15, 2022ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Replacement back up batteries Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJun 15, 2022ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall (1) JOBST Compri2 The folding boxes within the shipping case are mislabeled. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, New Hampshire, Ohio, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Centricity Universal Viewer Zero Footprint Client Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and… Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide, and 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Centricity Enterprise Web Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and… Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide, and 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Centricity Radiology RA600 Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and… Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide, and 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Centricity Cardiology CA1000 Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and… Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide, and 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Centricity PACS RA1000 Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and… Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide, and 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall STORZ KARL STORZ-ENDOSKOPE The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe Product labeled incorrectly. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall 1.8mm Truss Wire 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 15, 2022ClassClass IIStatusCompletedWhereNationwide, and Arizona, Connecticut, Georgia, North Carolina, Ohio, Texas and Virginia named
- Medical device recall Triathlon Tritanium Tibial Component (Size 6) Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package… Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Idaho, Indiana, Kansas, Michigan, Nevada, Pennsylvania, Tennessee, Washington and West Virginia named
- Medical device recall PX200 Emergency Relief Bed Product label was printed without the UDI number and warning label was printed with the incorrect weight capacity. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts, New Jersey and Pennsylvania named
- Medical device recall Oakworks Bed (Emergency Field Bed) The warning label was printed with the incorrect weight capacity. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts, New Jersey and Pennsylvania named
- Medical device recall Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499) The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734… The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259… The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sensis, Programmable Diagnostic Computer Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall V8 Immunodisplacement Kit Due to microbial growth causing interference with interpretation. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 15, 2022ClassClass IIStatusOngoingWhereFlorida, Missouri, Ohio and Texas
- Medical device recall Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and… if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an… Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional… if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an… Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 A Size 2 trial baseplate was assembled with Size 1 instrument sets. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereAlaska, California, Connecticut, Indiana, Massachusetts, New Jersey and Pennsylvania
- Medical device recall Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the… Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a… Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide, and Maryland, Minnesota, North Dakota, Nebraska, New York, Pennsylvania and Virginia named
- Medical device recall Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing,… Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a… Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide, and Maryland, Minnesota, North Dakota, Nebraska, New York, Pennsylvania and Virginia named
- Medical device recall Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No.… Potential for the tip of the electrode to detach during use. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement Report8 statesnamed in where it went PublishedJun 15, 2022ClassClass IIStatusOngoingWhereFlorida, Maryland, Michigan, New Mexico, New York, Pennsylvania, Tennessee and Virginia
- Medical device recall Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on… Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on… Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence… Discontinuation of the Emergency Alert watch or pendant will no longer connect to the emergency alert system for all models. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall regard GS0098C - RESUSABLE RT BRONCH Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportFloridathe one state its words name PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Reliance Synergy Washer/Disinfector The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the… Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 15, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Indiana, Kansas, Minnesota, Mississippi, South Carolina and Tennessee named
- Medical device recall In-Line ventilator adaptor There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 8, 2022ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia 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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