Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip… Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou… Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe… The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. Class IIIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe… The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. Class IIIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe… The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. Class IIIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall EsoFLIP, 30mm BALLOON DILATION CATHETER Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to… Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Quarantined product was inadvertently distributed Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 19, 2024ClassClass IIStatusCompletedWhereNationwide, and New Jersey named
- Medical device recall MyoSPECT System There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a… Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, North Dakota, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504… The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable… Class IIFDA’s classJun 19, 2024in FDA’s Enforcement Report38 statesnamed in where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Wisconsin, West Virginia and Wyoming
- Medical device recall OMTech Desktop Laser Engraver Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stimuplex A, 30 DEG, 24GX1”, 0.55x25mm, Catalogue Number: 4894251. The devices are labeled “not made with DEHP” or the DEHP free symbol; however, the glue used contains traces of DEHP. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stimuplex A, 30 DEG, 21GX4”, 0.80x100mm, Catalogue Number: 4894260 The devices are labeled “not made with DEHP” or the DEHP free symbol; however, the glue used contains traces of DEHP. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stimuplex A, 30 DEG, 20GX6”, 0.90x150mm, Catalogue Number: 4894278 The devices are labeled “not made with DEHP” or the DEHP free symbol; however, the glue used contains traces of DEHP. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stimuplex A, 30 DEG, 22GX2”, 0.70x50mm, Catalogue Number: 4894502 The devices are labeled “not made with DEHP” or the DEHP free symbol; however, the glue used contains traces of DEHP. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in… CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen… Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be… Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall CODMAN EVD BACTISEAL 1.9mm I.D Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Aeos Robotic Digital Microscope Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated… Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Illinois, Indiana, Kentucky, Michigan, North Carolina, Nebraska, Oklahoma, South Dakota and Texas named
- Medical device recall US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Concentrate Flow was exceeding the maximum 19.9 bar set point. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Indiana and Wisconsin named
- Medical device recall VITROS Immunodiagnostic Products Anti HBs Calibrators Potential for positively biased results due to signal reduction over shelf life. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032 Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide, and Tennessee named
- Medical device recall Vaporizer Sevoflurane Maquet Filling Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2024in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 12, 2024ClassClass IStatusOngoingWhereCalifornia, Colorado, Indiana, Missouri, Oregon, Virginia and Washington
- Medical device recall Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 12, 2024ClassClass IStatusOngoingWhereNationwide, and California, Colorado, Delaware, Illinois, Indiana, Massachusetts, Minnesota, Pennsylvania and Puerto Rico named
- Medical device recall Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 12, 2024ClassClass IStatusOngoingWhereNationwide, and California, Colorado, Delaware, Illinois, Indiana, Massachusetts, Minnesota, Pennsylvania and Puerto Rico named
- Medical device recall Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 12, 2024ClassClass IStatusOngoingWhereNationwide, and California, Colorado, Delaware, Illinois, Indiana, Massachusetts, Minnesota, Pennsylvania and Puerto Rico named
- Medical device recall MEGADYNE MEGA SOFT Pediatric Patient Return Electrode Reports of patient burns. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall LOSPA Tibial Insert Due to unsupported 10 year expiration date. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Michigan, Pennsylvania and Texas named
- Medical device recall LOSPA Patella Component Due to unsupported 10 year expiration date. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Michigan, Pennsylvania and Texas named
- Medical device recall Syringes labeled as: a) SYR 10ML L/L CONTROL These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their… Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their… Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of… Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in… Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of… Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight… Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of… Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction… Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement Report31 statesnamed in where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Arial mobile application The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app to receive alerts for all pending alarm… Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh… Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Colorado, Illinois, Kansas, Massachusetts, Maine, New Jersey, New York, Pennsylvania, South Dakota, Washington and Wisconsin named
- Medical device recall IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of… Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Virginia named
- Medical device recall Newport s N-LHP-928(j) units if According to 21 CFR 1040.10(f)(4), each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leica HistoCore PEGASUS Tissue Processor Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles… Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR… Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR… Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR… Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVANTA VXT, 5X40, 1GDS, NH, STR-SW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ADVANTA VXT, 6X40, 1GDS, NH, STR-SW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ADVANTA VXT, 8X40, 1GDS, NH, STR-SW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ADVANTA VXT, 5X50, 1GDS, NH, STR-SW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico 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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