1084 alerts recorded, refreshed every six hours. Filter by source or category.
Shanghai United Imaging Healthcare is recalling its Computed Tomography X-ray System, model uCT ATLAS with software. A software problem can hide patient images when certain functions are used, possibly requiring rescans and exposing patients to extra radiation. Users should stop using the affected function and contact the company for a software update.
Shanghai United Imaging Healthcare Co., Ltd. is recalling its Computed Tomography X-ray System, model uCT 780 with software. A software problem can hide patient images when certain functions are used, possibly requiring rescans, affecting patients scanned with this system nationwide. Patients should contact their healthcare provider or imaging facility to ask about their scan and any needed follow-up.
Shanghai United Imaging Healthcare's uMI Panvivo S Positron Emission Tomography and Computed Tomography System with software is affected. A software problem can hide patient images when Split or Local function is used and multiple exams are merged, possibly requiring rescans for patients. The firm initiated a voluntary recall, so consumers should contact their imaging provider for instructions.
ASP Global is recalling its Expressaire Disposable Tourniquet Cuff, model A70107012, a sterile cuff used to control blood flow during surgery. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which may expose surgical patients to a product past its safe usable life. Consumers should immediately stop using affected cuffs, check expiration dates, and contact ASP Global for replacement.
Philips Spectral CT 7500 with software V5.2.x is affected. The bolus tracking application may crash and keep scanning after the contrast threshold, exposing patients to extra radiation. Users must follow the FDA-mandated recall instructions for the affected software.
ASP Global is recalling its Disposable Tourniquet Cuff, 18" x 4" 2-Line, Red, model ASP-564007, distributed nationwide. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which could expose patients to non-sterile or ineffective devices during surgery. Consumers and healthcare providers should stop using affected cuffs and follow the firm's recall instructions for return or disposal.
ASP Global, LLC is recalling its Expressaire Disposable Tourniquet Cuff, 38" x 4" 1-Line, model 564044. The cuffs have an incorrect expiration date, labeled with a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially ineffective devices. Consumers should check the expiration date on affected cuffs and contact ASP Global for instructions.
ASP Global is recalling Expressaire Disposable Tourniquet Cuffs, model 564007, distributed nationwide. The cuffs are labeled with a 10-year shelf life instead of the correct 5 years, which could affect their performance during surgery and put patients at risk. Consumers should stop using affected cuffs and contact ASP Global for return or replacement.
Cardinal Health 200, LLC is recalling Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets, including GU Davinci kits and Colorectal packs with specific catalog numbers. The tube sets may leak fluid from the handpiece onto the floor, creating a slip and fall hazard for users. Consumers should stop using the affected kits and follow the recall notice.
Philips North America is recalling Evolution upgrade 1.5T and 3.0T MR systems with specific model numbers. The systems export diffusion tensor imaging data with incorrect diffusion directions, which can cause third-party tractography software to misprocess brain nerve fiber mapping. Users should contact Philips North America for instructions on correcting the issue.
Shanghai United Imaging Healthcare's uMI Panorama 35 positron emission tomography and computed tomography system with software is affected. A software problem can hide patient images on the Patient Administration interface, possibly requiring rescans for patients. Consumers should contact their imaging facility or the manufacturer for recall instructions.
ASP Global disposable tourniquet cuffs, model ASP-564012, are affected. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially compromised sterility. Consumers should check the expiration date on their cuffs and contact ASP Global for replacement if affected.
Shanghai United Imaging Healthcare Co., Ltd. is recalling its Computed Tomography X-ray System, Model uCT 550 with software. A software problem when Split or Local function is enabled and multiple RIS exams are merged can hide patient images, possibly requiring rescans for patients. Consumers should contact their imaging facility or healthcare provider for guidance and follow-up.
Philips is recalling its Ingenia 1.5T, 1.5T CX, and 1.5T S MRI systems with software versions R11, R12, and R13. The affected systems export diffusion tensor imaging scans with incorrect diffusion directions, which can cause third-party tractography software to misreconstruct brain nerve fiber pathways. Users should stop using the affected export feature and contact Philips for a software correction.
ASP Global LLC is recalling Expressaire Disposable BB Tourniquet Cuffs, model A70107014, used during surgery. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially unsafe devices. Consumers should stop using affected cuffs, check the expiration date, and contact ASP Global for return or replacement.
Penumbra Inc. is recalling its Penumbra System RED 62 Reperfusion Catheter, model THNDRRED62SKIT. The catheter may fracture during use, posing a risk to patients undergoing procedures. Consumers should contact their healthcare provider or Penumbra Inc. for instructions on returning the device.
Medline Industries is recalling Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, specifically hand pendants. The hand control pendant and wiring may overheat, causing smoking, sparking, melting, burning, or fire, affecting users nationwide and in Puerto Rico, Guam, Bermuda, Canada, and Panama. Consumers should stop using the affected pendants and contact Medline Industries for further instructions.
American Nitrile Operations LLC is recalling Performance Pro blue nitrile examination gloves, models 72-RM50601 through 72-RM50604. The gloves may have tears, missing fingers, or debris, exposing healthcare personnel and patients to infectious pathogens or chemical agents. Consumers should stop using the affected gloves and follow the recall notice for return instructions.
The recall affects Percussionaire Corporation's Intrapulmonary Percussive Ventilation IPV-2C and Phasitron 5 devices. Using these devices with volatile anesthetic delivery systems can change anesthetic levels, causing dangerous effects in patients. Consumers should read the updated warning and stop using the device with volatile anesthetic systems.
The recall affects Mastisol Skin Adhesive in surgical convenience trays and kits from Ferndale Laboratories, Medline, and Custom Interventional Pain Management. Manufacturing issues with the liquid skin adhesive pose a hazard to patients undergoing procedures using these trays. Consumers should stop using affected kits and follow the firm's recall instructions for return.
ASP Global is recalling Expressaire Disposable Tourniquet Cuffs, model A70107008, a 24x4 inch sterile cuff used during surgery. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5-year shelf life, which may expose patients to a device that is no longer safe or effective. Consumers and healthcare providers should stop using affected cuffs and contact ASP Global for replacement or return.
Philips IntraSight Plus devices with reference numbers 797423 and 797417 are recalled. The software may mix up image data between patients, risking incorrect diagnosis or treatment for those patients. Consumers should contact their doctor or Philips for guidance.
American Contract Systems Inc medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays are affected. The contaminated wipes can cause skin irritation, erythema, or mild inflammation, and discarding them may increase infection risk for patients. Consumers should stop using the affected kits and contact American Contract Systems Inc for instructions.
ASP Global's Expressaire Disposable Tourniquet Cuff, model 553322, is affected. The cuffs have an incorrect expiration date, labeled with a 10-year shelf life instead of the validated 5 years, exposing patients to potentially ineffective sterilization during surgery. Consumers should stop using affected cuffs and contact ASP Global for instructions.
ASP Global is recalling its Disposable Tourniquet Cuff, 12" x 3.5" 2-Line, Plum, model ASP-564003. The cuffs have an incorrect expiration date showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially ineffective sterilization. Consumers should check the expiration date on affected cuffs and stop using them if they are older than five years, then follow the recall instructions.
ASP Global is recalling its Expressaire Disposable Tourniquet Cuff, model A70107007, a sterile cuff used to control blood flow during surgery. The cuffs, made between September 2016 and March 2023, carry an incorrect 10-year expiration date instead of the validated 5-year shelf life, exposing patients to potentially ineffective or non-sterile devices. Consumers should stop using affected cuffs and contact ASP Global for replacement or return instructions.
ASP Global, LLC is recalling Expressaire Disposable Tourniquet Cuffs, model 564010, distributed nationwide. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which may affect sterility and function for surgical patients. Consumers should stop using affected cuffs, check expiration dates, and contact ASP Global for replacement.
The recall affects the Quantum PureFlow Standard Heat Exchanger High Flow 3/8, model HX55W-S0, made by Spectrum Medical. A blood-to-glycol leak in the heat exchanger can expose patients to glycol during cardiopulmonary bypass procedures. Consumers should stop using the recalled device and contact Spectrum Medical for instructions.
Cardinal Health is recalling Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets used in gynecologic laparoscopy and robotic procedures. The handpieces may leak fluid onto the floor, creating a slip and fall hazard for operating room staff. Consumers should stop using the affected kits and contact Cardinal Health for instructions.
Expressaire Disposable Tourniquet Cuff, model 564017, made by ASP Global, is being recalled. The cuff has an incorrect expiration date showing a 10-year shelf life instead of the validated 5 years, putting surgical patients at risk of using a non-sterile or ineffective device. Consumers should stop using affected cuffs, verify the expiration date, and contact ASP Global for a replacement.
Philips North America MR 7700 systems with model numbers 782120, 782153, 782155, and 782199 and software versions R11, R12, and R13 are affected. The hazard is incorrect diffusion direction data in Enhanced MR DICOM exports, which can cause third-party tractography software to misprocess DTI scans for brain imaging. The firm initiated a voluntary recall.
The recall affects MPR brand Single Use Tourniquet Cuff 44" 2 Line, model DT-7044-02Q. The cuffs have an incorrect expiration date, showing 10 years instead of the validated 5-year shelf life, exposing surgical patients to risk of device failure. Consumers should stop using affected cuffs and contact ASP Global for return or replacement instructions.
Percussionaire Corporation is recalling its Intrapulmonary Percussive Ventilation (IPV HC) and Phasitron (P5-HC) devices. Using these devices with volatile anesthetic delivery systems can cause unsafe anesthesia levels, leading to serious heart, brain, or sedation problems in patients. Consumers must stop using IPV with volatile anesthetics and follow the updated warning label.
Shanghai United Imaging Healthcare's Computed Tomography X-ray System, model uCT 530 with software, is affected. A software problem can hide patient images on the Patient Administration interface, possibly requiring rescans, affecting patients scanned with this system nationwide. Consumers should contact their healthcare provider to determine if their imaging was affected and what to do next.
Merit Medical Systems' Embosphere microspheres in 500-700, 700-900, and 900-1200 micrometer 2 mL syringes are affected. The packaging may have holes that compromise the sterile barrier, exposing patients to infection during embolization procedures. Consumers should contact Merit Medical Systems for return and replacement instructions.
Spectrum Medical's Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W (model HX55V-S0W) is affected. A blood-to-glycol leak in the heat exchanger poses a hazard to patients during cardiopulmonary bypass. Consumers should follow the recall instructions from Spectrum Medical.
ASP Global is recalling Expressaire Disposable BB Tourniquet Cuffs, model A70107017, distributed nationwide. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially ineffective devices. Consumers and healthcare providers should stop using affected cuffs and return them to ASP Global.
ASP Global is recalling Expressaire Disposable Tourniquet Cuffs, model A70107001, an 8-inch by 2.5-inch light blue sterile cuff used during surgery. The cuffs, made between September 2016 and March 2023, carry an incorrect 10-year expiration date instead of the validated 5-year shelf life, which could expose patients to ineffective or unsafe devices. Consumers should check the expiration date on affected cuffs and stop using them, then contact ASP Global for instructions on returning or replacing the product.
Philips is recalling Ingenia 3.0T and 3.0T CX MRI systems with software versions R11, R12, and R13. The DTI scan exports contain incorrect diffusion directions, so third-party tractography software may misprocess brain nerve pathway images, affecting patients. Users should stop using the affected software and contact Philips for correction.
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories are affected. The hand control pendant and wiring may overheat, causing smoking, sparking, melting, burning, or fire, posing a risk to users. Consumers should stop using the affected beds and contact Medline Industries for a remedy.
ASP Global LLC is recalling Expressaire Disposable Tourniquet Cuffs, model 553323, 30 by 4 inches. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially ineffective blood flow control. Consumers should locate affected cuffs, verify the expiration date, and stop using or return them to the company.
Ajanta Pharma USA Inc. is recalling Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottles, distributed nationwide in the US. The tablets failed dissolution specifications, meaning they may not release the drug properly, posing a risk to patients who take this prescription medication. Consumers should stop using the recalled tablets and contact their pharmacist or doctor for a replacement or guidance.
Par Health USA, LLC is recalling Buprenorphine Hydrochloride Injection 0.3 mg/mL single-dose vials, manufactured for Endo USA. The product may crystallize, posing a hazard to patients receiving the injection nationwide. Consumers should contact their healthcare provider or pharmacist for instructions.
The recalled product is Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ, distributed by Rugby Laboratories. The hazard is microbial contamination of the topical product, exposing consumers in Illinois. Consumers should stop using the product and return it to the place of purchase.
Apotex Corp. is recalling Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottles, distributed nationwide. The tablets failed dissolution specifications, meaning they may not release the drug properly, posing a risk to patients who take this prescription. Consumers should stop using the recalled lot and contact their pharmacist or doctor for a replacement or guidance.
TerSera Therapeutics LLC is recalling Zoladex (goserelin) implant 3.6 mg single-use syringes. The product was exposed to non-temperature-controlled conditions for 25.5 hours, potentially affecting patients nationwide. Consumers should stop using the product and contact their healthcare provider or pharmacy for instructions.
The recall affects Aurolab Trust FOCUS PI Hypromellose 0.7% Formula sterile eye drops in 10 mL vials. The hazard is lack of assurance of sterility, which exposes users to risk of infection. Consumers must stop using the recalled eye drops and contact the firm or return them as directed.
Amneal Pharmaceuticals is recalling its Estradiol Gel, 0.1%, 0.25 mg, sold in 30-packet cartons nationwide. The packets may be empty or partially full, exposing patients to an incorrect dose of this prescription hormone gel. Consumers should stop using the affected product and contact Amneal Pharmaceuticals for further instructions.
Rugby Laboratories' Benzoyl Peroxide Wash, USP, 10%, in 5 oz and 8.5 oz bottles, is recalled. The topical product may be contaminated with microbes, posing a risk to consumers using it. Consumers should stop using the recalled wash and return or discard it.
Todd's Seeds Alfalfa Sprouting Seeds in resealable bags from 1/4 lb to 5 lb are affected. The seeds may be contaminated with E. coli and Salmonella, posing a risk to anyone who eats them. Consumers should not eat them and should discard or return them.
Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.