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 Percept PC BrainSense Implantable Neurostimulator (INS) The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJun 1, 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, 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 Invacare TDX SP2 The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles… Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedJun 1, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Cardioblate” Gemini”-s Irrigated RF Surgical Ablation System Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 1, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Idaho, Kansas, Massachusetts, Minnesota, Missouri, North Dakota, New Jersey, New York, Utah and Wisconsin named
- Medical device recall Surgical Suture Kit There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall INTERTAN 1.5 NAIL 13mm X 42cm 130DEG Right nails were anodized, marked, and labelled as left nails and vice versa Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJun 1, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Georgia, Indiana, Missouri, North Carolina, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall SUR-FIT Natura S4S Durahesive Wafer 70MM Firm received 10 complaints of skin barrier delamination issues (e.g. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Delaware, Florida, Illinois, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall AC-powered adjustable medical beds with built-in electric DC actuators and controls. There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the… Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Minnesota, Missouri, North Carolina, North Dakota, New York, Oklahoma, Pennsylvania, Texas, Utah, Washington and Wisconsin named
- Medical device recall AC-powered adjustable medical beds with built-in electric DC actuators and controls. There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the… Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Minnesota, Missouri, North Carolina, North Dakota, New York, Oklahoma, Pennsylvania, Texas, Utah, Washington and Wisconsin named
- Medical device recall progenamatrix Human Keratin Matrix, sterile, Rx, with the following Inner pouch seal may be inadequate resulting in lack of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Georgia, Tennessee and Texas named
- Medical device recall ABX Pentra Calcium AS CP, Reagent 90 mL Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall Avanos Cortrak 2 Enteral Access System (EAS) Product labeling is being modified. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Atrium Advanta V12 Covered Stent System (OUS only) Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 25, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 25, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall iCast Covered Stent System Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 25, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 25, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW. Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer’s requirements. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement Report34 statesnamed in where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Texas, Virginia, Washington and West Virginia
- Medical device recall EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible… Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible… Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible… Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible… Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MicroScan WalkAway-40 plus Instrument WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont and Washington named
- Medical device recall MicroScan WalkAway-96 plus Instrument WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont and Washington named
- Medical device recall DxM 1040 MicroScan WalkAway Instrument WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont and Washington named
- Medical device recall DxM 1096 MicroScan WalkAway Instrument WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont and Washington named
- Medical device recall MicroScan WalkAway-40 plus Reconditioned Instrument WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont and Washington named
- Medical device recall MicroScan WalkAway-96 plus Reconditioned Instrument WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont and Washington named
- Medical device recall Total Resources International First Aid Kits ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into Total Resources Intl kits. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 25, 2022ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall Total Resources International First Aid Kits ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into Total Resources Intl kits. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 25, 2022ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Illinois, Minnesota, North Carolina and Rhode Island named
- Medical device recall Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement Report16 statesnamed in where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Maine, Michigan, Nebraska, Ohio, Pennsylvania, Texas, Vermont and Washington
- Medical device recall NaviCare Nurse Call System provides a comprehensive communication and information system that places patient… Firm discovered a firmware memory leak with a supplier-manufactured component. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 25, 2022ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medical device recall Voalte Nurse Call System provides a comprehensive communication and information system that places patient… Firm discovered a firmware memory leak with a supplier-manufactured component. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 25, 2022ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medical device recall Dragonfly OpStar Imaging Catheter There is a potential that the proximal marker may separate from the imaging catheter FDA Class I, its most serious class Class IFDA’s class (needs attention)May 25, 2022in FDA’s Enforcement Report43 statesnamed in where it went PublishedMay 25, 2022ClassClass IStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall BioPlex 2200 Performance concerns for the CMV IgM analyte. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Florida, Hawaii, Iowa, Illinois, Michigan, Minnesota, Nebraska, New York, Tennessee, Texas and Washington named
- Medical device recall CK MB Calibrator, Catalogue Number CK2393 Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Class IIIFDA’s classMay 25, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 25, 2022ClassClass IIIStatusTerminatedWherePuerto Rico and West Virginia
- Medical device recall LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5 It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 25, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Illinois, North Carolina, South Carolina and Virginia named
- Medical device recall Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to… Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportSouth Carolinathe one state its words name PublishedMay 25, 2022ClassClass IIStatusTerminatedWhereSouth Carolina
- Medical device recall Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits… Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereFlorida, Georgia, Pennsylvania and Washington
- Medical device recall HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HeartWare Ventricular Assist Device (HVAD) System Controller Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HeartWare Ventricular Assist Device (HVAD) System Controller Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HeartWare Ventricular Assist Device (HVAD) System Controller Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HeartWare Ventricular Assist Device (HVAD) System Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder… Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall VITRIGUARD, CARRIER, CLEAR Products in this lot may have compromised barrier seals, introducing a risk to sterility. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement Report10 statesnamed in where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereArizona, California, Florida, Illinois, Michigan, Missouri, New York, Oregon, Texas and West Virginia
- Medical device recall VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL Higher than normal “No Call Internal Control failures” due to a missing reagent within a small subset of the extraction tray lot. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device… Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare… Class IIFDA’s classMay 25, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Turbett Surgical Container, TS1500 Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use. Class IIFDA’s classMay 25, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 25, 2022ClassClass IIStatusOngoingWhereCalifornia, New York and Pennsylvania
- Medical device recall VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 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 VITROS Immunodiagnostic Products LH 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
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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