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 Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal… COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 16, 2022ClassClass IStatusOngoingWhereNationwide, and California, North Carolina, Nevada, Ohio, Tennessee and Texas named
- Medical device recall COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 16, 2022ClassClass IStatusOngoingWhereNationwide, and California, North Carolina, Nevada, Ohio, Tennessee and Texas named
- Medical device recall Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format There are lower than expected MICs for some gram negative species. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMar 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a… Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an… Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HeartWare Ventricular Assist Device (HVAD) System Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source… Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dispensing Pins for Air Inlet Filter, Product This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMar 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Jersey, Ohio, Pennsylvania, Tennessee, Texas and Utah named
- Medical device recall 1688 Camera Control Unit (CCU) A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile… Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No Kits were labeled with incorrect expiration dates. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement Report11 statesnamed in where it went PublishedMar 16, 2022ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Florida, Hawaii, Massachusetts, Montana, New Jersey, New York, Pennsylvania, Tennessee and Texas
- Medical device recall RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all… Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ExacTrac Dynamic software The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement Report20 statesnamed in where it went PublishedMar 16, 2022ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Florida, Georgia, Indiana, Kentucky, Maryland, Missouri, Mississippi, North Carolina, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Texas, Virginia and Washington
- Medical device recall VITROS Chemistry Products VersaTips The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CoolSeal Generator A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can… Class IIFDA’s classMar 16, 2022in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 16, 2022ClassClass IIStatusTerminatedWhereDelaware, Florida, Missouri, New York and Pennsylvania
- Medical device recall NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip A risk for product contamination was identified for the affected product lot. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, Maryland, Michigan and New York named
- Medical device recall Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to… During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the… Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMar 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Illinois, Louisiana, Maryland, New York, Pennsylvania, Texas and Washington named
- Medical device recall Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to… During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the… Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMar 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Illinois, Louisiana, Maryland, New York, Pennsylvania, Texas and Washington named
- Medical device recall Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients… individual components have been labelled with incorrect colours. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Hawaii, Missouri, Pennsylvania and Tennessee named
- Medical device recall NIM TRIVANTAGE EMG Endotracheal Tube There is potential for multiple issues due to a manufacturing nonconformity. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PuraSinus Absorbable Nasal Hemostat The boxes used by the shipper were not validated for use during transport. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Ohio named
- Medical device recall HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs. Class IIIFDA’s classMar 16, 2022in FDA’s Enforcement ReportAlaskathe one state its words name PublishedMar 16, 2022ClassClass IIIStatusTerminatedWhereAlaska
- Medical device recall PCA 4000 Curing Units The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with… When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still… Class IIFDA’s classMar 16, 2022in FDA’s Enforcement Report12 statesnamed in where it went PublishedMar 16, 2022ClassClass IIStatusOngoingWhereFlorida, Illinois, Kansas, Louisiana, Michigan, New Jersey, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Digital Angiography System Bransist safire Generator Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 9, 2022ClassClass IIStatusOngoingWhereCalifornia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Washington
- Medical device recall Digital Angiography System Shimadzu Trinias Generator Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 9, 2022ClassClass IIStatusOngoingWhereCalifornia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Washington
- Medical device recall Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 9, 2022in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 9, 2022ClassClass IStatusTerminatedWhereCalifornia, Florida, New Jersey, New York, Pennsylvania and South Carolina
- Medical device recall Philips Respironics V60 Ventilator A limited number of ventilators were assembled with expired adhesive. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 9, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 9, 2022ClassClass IStatusOngoingWhereArkansas, California, Florida, Georgia, Indiana, Louisiana, Maryland, Missouri, New York, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Philips Respironics V60 Plus Ventilator A limited number of ventilators were assembled with expired adhesive. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 9, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 9, 2022ClassClass IStatusOngoingWhereArkansas, California, Florida, Georgia, Indiana, Louisiana, Maryland, Missouri, New York, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium Product was labelled with the incorrect manufacturing and distribution dates. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No Returned test kits were erroneously shipped to customers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 9, 2022in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 9, 2022ClassClass IStatusTerminatedWhereTexas
- Medical device recall Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift The design of the seats did not consistently have the adequate strength required to support the customers weight with continued use. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 9, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Kentucky, New Mexico, Pennsylvania, South Dakota and Tennessee named
- Medical device recall Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Kentucky, New Mexico, Pennsylvania, South Dakota and Tennessee named
- Medical device recall Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Kentucky, New Mexico, Pennsylvania, South Dakota and Tennessee named
- Medical device recall Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Kentucky, New Mexico, Pennsylvania, South Dakota and Tennessee named
- Medical device recall Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Kentucky, New Mexico, Pennsylvania, South Dakota and Tennessee named
- Medical device recall Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Kentucky, New Mexico, Pennsylvania, South Dakota and Tennessee named
- Medical device recall Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Kentucky, New Mexico, Pennsylvania, South Dakota and Tennessee named
- Medical device recall Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Kentucky, New Mexico, Pennsylvania, South Dakota and Tennessee named
- Medical device recall Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Kentucky, New Mexico, Pennsylvania, South Dakota and Tennessee named
- Medical device recall Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Kentucky, New Mexico, Pennsylvania, South Dakota and Tennessee named
- Medical device recall AU/DxC AU Magnesium Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement Report50 statesnamed in where it went PublishedMar 9, 2022ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Regard, TOTAL HIP - SPRINGFIELD Products are mislabeled with the incorrect product identification on individual kit labeling. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportMissourithe one state its words name PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Microbiologics QC Sets and Panels: Helix Elite Real-time shelf life testing failed at 24 months Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, District of Columbia, Florida, Iowa, Idaho, Kansas, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington and West Virginia named
- Medical device recall Microbiologics QC Sets and Panels Real-time shelf life testing failed at 24 months Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, District of Columbia, Florida, Iowa, Idaho, Kansas, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington and West Virginia named
- Medical device recall Helix Elite” Molecular Standards: Inactivated Standard Real-time shelf life testing failed at 24 months Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, District of Columbia, Florida, Iowa, Idaho, Kansas, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington 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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