602 alerts recorded, refreshed every six hours. Filter by source or category.
The affected product is the Steris Corporation VERIFY Biological/Integrator Challenge Pack, model LCB006. The spore population may fall below specification, causing a false negative that could expose users of steam sterilization cycles to ineffective sterilization. The recall is voluntary and initiated by the firm.
Safeguard US Operating LLC is recalling its Battle Bandage and many stocked IFAK and trauma kits containing it. The compression bandage may be degraded, allowing foreign material into wounds and causing infection or other harm to users. Consumers should stop using affected products and follow the FDA recall notice for return instructions.
Nihon Kohden CNS-6200 Series Central Nurse Station, model CN-6201, with software versions 01-03 through 02-40, is affected. A cybersecurity vulnerability could disrupt centralized monitoring and alarm visualization, exposing medical professionals and patients. Users should contact Nihon Kohden America to address the issue.
The recall affects Onkos Surgical My3D Personalized Pelvic Implant, Porous, Left, REF PV-ACREC-04M. The hazard is that implants were mixed up and sent to wrong customers, so patients may receive a device meant for someone else. Consumers should contact Onkos Surgical or their healthcare provider to verify and return the implant.
Medline Industries is recalling its Bariatric Basic Steel Blue Rollator, a four-legged metal walker. The front fork stem bolt/wheel assembly may disconnect, causing the front wheels to loosen or detach and leading to falls with head trauma, fractures, or other critical injuries for users. Consumers should stop using the rollator and contact Medline Industries for further instructions.
Philips Medical Systems Spectral CT and Spectral CT 7500 RT with certain software versions are affected. Software issues can cause image artifacts, wrong slice thickness, or unintended system motion, affecting patients and operators. Users should contact Philips Medical Systems for instructions.
The recall affects Medtronic MiniMed Flex Insulin Pumps, models MMT-8062 and MMT-8072. Some pumps were released without passing all functional tests, which may cause issues such as inoperability, disconnections, or inaccurate insulin delivery for users. Consumers should contact Medtronic MiniMed for recall instructions.
Steris Corporation's VERIFY Biological Steam Test Pack Model S3065 is affected. The spore population may fall below specification, causing a false pass in steam sterilization monitoring, exposing healthcare users to ineffective sterilization. The recall is voluntary and firm initiated, but no consumer action is specified in the notice.
Stryker Sustainability Solutions is recalling its BARD EP XT Decapolar Steerable Diagnostic EP Catheter, REF 201007. A breached sterile barrier may expose patients to particulate embolization, infection, thrombus, or granuloma formation. Users should stop using the affected catheters and return them to Stryker.
Philips North America is recalling its SmartPath to dStream software for 1.5T, 3.0T, XR and 3.0T, and Ingenia Elition X MR systems. The software exports diffusion tensor imaging scans with incorrect diffusion directions, which can cause third-party tractography software to misprocess brain nerve pathway data. Users should stop using the affected software versions and contact Philips for correction.
Karl Storz HOPKINS Telescope 30°, 4mm (REF 10005BA) is affected. The inside packaging label for the eyepiece is incorrect, which could mislead users during endoscopic procedures. Consumers should stop using the affected telescope and contact Karl Storz for return or replacement.
ASP Global is recalling its Disposable Tourniquet Cuff, 24" x 4", model ASP-564008. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which could affect patients during surgery. Consumers should stop using affected cuffs and contact ASP Global for a replacement or refund.
ASP Global is recalling its MPR Single Use Tourniquet Cuff 15-inch 1 Line (10), model DT-7115-01Q. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which may expose patients to an expired device during surgery. Consumers should check the expiration date on their cuffs and follow the recall instructions from ASP Global.
ASP Global's Expressaire Disposable Tourniquet Cuff, model A70107002, is affected. The cuffs have an incorrect expiration date, labeled as 10 years instead of the validated 5-year shelf life, exposing surgical patients to potentially unsafe devices. Consumers should check the expiration date and stop using any cuff manufactured between September 2016 and March 2023 that is older than five years.
The NOxBOXi Nitric Oxide Delivery System, model NOXBOX-I, made by NOXBOX Ltd, is affected. A manufacturing issue with certain oxygen sensors can cause irregular oxygen readings, exposing patients using the device. Consumers should follow the firm's voluntary recall instructions.
Heraeus Medical GmbH is recalling PALACOS R pro 40 and PALACOS R pro 80 bone cement, models 5081286 and 5081287. The cement may leak monomer liquid, exposing patients and healthcare workers to a chemical hazard. Users should stop using the recalled product and contact Heraeus Medical for instructions on returning it.
Percussionaire Corporation is recalling its Intrapulmonary Percussive Ventilation IPV 1 and Phasitron 5 Breathing Circuit with Unified Connector. Using these devices with volatile anesthetic delivery systems can alter anesthesia levels, causing serious effects like abnormal heart rate, blood pressure changes, or awareness during anesthesia for patients. Consumers must follow the updated warning and not use the IPV with volatile anesthetic delivery systems.
ASP Global is recalling its Disposable Tourniquet Cuff, 44" x 4" 2-Line, Green, model ASP-564015. The cuff has an incorrect expiration date, labeled for 10 years instead of the validated 5-year shelf life, exposing surgical patients to potentially ineffective blood flow control. Consumers should stop using affected cuffs and return them to ASP Global for replacement.
ASP Global, LLC is recalling Expressaire Disposable Tourniquet Cuffs, model A70107013, a sterile cuff used in surgery. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which could affect patients during surgical procedures. Users should stop using affected cuffs and contact ASP Global for replacement or further instructions.
The recall affects Fisher Scientific Sure-Vue, McKesson CONSULT, Henry Schein One Step+, Alere, Cardinal Health, Medline, and Pro Advantage by NDC urine hCG tests. These tests may detect low hCG levels below stated sensitivity, causing false positive results for users. Consumers should stop using the recalled tests and follow the firm's recall instructions.
MPR brand Single Use Tourniquet Cuff 24" 2 Line, model DT-7024-02Q, is 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 ineffective tourniquets. Consumers should stop using affected cuffs and contact ASP Global for return or replacement.
The recall affects Expressaire Disposable Tourniquet Cuff, 34" x 4" 1-Line (CS 18) Blue, model A70107010. The cuff has an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing patients to potentially ineffective or unsafe use during surgery. Consumers must check the expiration date and not use the product beyond five years.
ASP Global is recalling Expressaire disposable tourniquet cuffs, model A70107009, 24" x 4" 2-line yellow. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which could affect patients during surgery. Consumers should stop using affected cuffs and contact ASP Global for return or replacement.
Shanghai United Imaging Healthcare's uMI 780 Positron Emission Tomography and Computed Tomography System is recalled. A software problem can hide patient images, possibly requiring rescans, affecting patients scanned with this device nationwide. Patients should contact their imaging facility to see if a rescan is needed.
MPR brand single-use tourniquet cuff model DT-7034-02Q is recalled. The cuffs have incorrect expiration dates, showing a 10-year shelf life instead of the validated 5 years, which may affect sterility and safety for surgical patients. Consumers should stop using affected cuffs and contact ASP Global for return or replacement.
ASP Global is recalling Expressaire Disposable Tourniquet Cuff, model A70107003, distributed nationwide. The product's label incorrectly states a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially ineffective cuffs. Consumers should locate affected cuffs, verify the manufacture date, and stop using any that are more than five years old.
ASP Global's Disposable Tourniquet Cuff, 44" x 4" 1-Line, Green, model ASP-564014, is affected. The cuff is labeled with a 10-year shelf life instead of the correct 5 years, exposing patients to possible failure during surgical use. Consumers should check the expiration date and stop using the cuff after five years from manufacture.
Philips North America is recalling its MR 7700 system, model REF 782130, with software versions R11, R12, and R13. The affected software exports incorrect diffusion directions in DTI scans, which can cause third-party tractography software to misprocess brain nerve pathway mapping. Users should contact Philips to arrange for the software upgrade.
The recall affects MPR brand Disposable Tourniquet Cuff 18" 2 Line (10), model DT-7218-02Q, made by ASP Global, LLC. The cuffs have an incorrect expiration date showing a 10-year shelf life instead of the validated 5 years, posing a risk to patients during surgery. Consumers should check the expiration date on the cuff and contact ASP Global for instructions.
ASP Global's Disposable Tourniquet Cuff, 24" x 4" 2-Line, Yellow, model ASP-564009, is affected. The cuff has an incorrect expiration date, labeled with a 10-year shelf life instead of the validated 5 years, affecting patients in surgical procedures. Consumers should check the expiration date and not use the cuff if it is older than five years.
ASP Global is recalling Expressaire Disposable Tourniquet Cuffs, model 564006, 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 products. Consumers should check the expiration date and stop using any cuff older than five years.
ASP Global is recalling its Expressaire Disposable Tourniquet Cuff, model A70107011, a sterile cuff used during surgery. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing patients to potentially ineffective sterilization. Consumers should stop using the recalled cuffs and follow the firm's recall instructions for return or replacement.
Percussionaire Corporation is recalling its Intrapulmonary Percussive Ventilation IPV-1C and Phasitron 5 devices. Using them with volatile anesthetic delivery systems may alter anesthetic levels, leading to serious effects such as muscle tone changes, heart rate problems, or awareness during anesthesia in patients. Consumers must stop this combined use and follow the updated warning in the instruction manual.
American Nitrile Operations LLC is recalling its Opportunity Pro blue nitrile patient examination gloves, models 72-50800 through 72-50804. The gloves may have tears, missing fingers, or debris, exposing healthcare workers and patients to infection or chemical harm. Consumers should stop using the recalled gloves and contact the company for return or disposal instructions.
Siemens Healthcare Diagnostics is recalling the Atellica CH Revised C-Reactive Protein (RCRP) test, material number 11537223. This product may give falsely elevated results, exposing patients to incorrect diagnoses or treatment decisions. Consumers should contact their healthcare provider to discuss their test results and any follow-up steps.
HeartSine Technologies is recalling its samaritan PAD defibrillators, including models 350P, 360P, and 450P. These devices were distributed without the required Maintenance Supplement, which describes an extra check every three months, leaving users without this important guidance. Consumers should contact HeartSine Technologies to obtain the missing supplement and ensure the extra check is performed.
ASP Global is recalling its Expressaire Disposable Tourniquet Cuff, model 564009, a sterile cuff used during surgery. 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 or non-sterile devices. Consumers should locate affected cuffs, verify expiration dates, and stop using or return them for replacement.
Shanghai United Imaging Healthcare's Positron Emission Tomography and Computed Tomography System, model uMI 550 with software, is affected. A software problem can hide patient images when certain functions are used, possibly requiring rescans for patients. Consumers should contact the imaging facility where they were scanned for further instructions.
ASP Global is recalling MPR Single Use Tourniquet Cuff 8" 2 Line, model DT-7108-02Q, sterile disposable tourniquet cuffs. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which may expose patients to ineffective or compromised devices during surgery. Consumers should stop using affected cuffs, verify expiration dates, and contact ASP Global for replacement or further instructions.
Heraeus Medical GmbH is recalling PALACOS R+G pro 40 and pro 80 bone cement, models 5081288 and 5081289. The product may leak monomer liquid, posing a hazard to patients and users. Consumers should be aware of the voluntary recall.
Heraeus Medical GmbH is recalling PALACOS MV pro 40 and pro 80 bone cement, models 5150633 and 5150635. The cement may leak monomer liquid, exposing patients and healthcare workers to potential harm. Consumers should stop using the affected products and contact Heraeus Medical for return or replacement.
American Contract Systems Inc is recalling medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays, model MHRB88AO. The wipes may be contaminated with a lubricant, causing skin irritation or increasing infection risk for patients. Consumers should check the model number and stop using the affected kits.
The recall affects Tandem Diabetes Care's t:slim mobile application for iOS, version 2.13 beta. The software bug prevents pairing with FreeStyle Libre 3 Plus sensors, so users cannot see glucose values or use automated insulin delivery, risking low or high blood sugar. Affected users must use their insulin pumps in manual mode.
The recall affects Expressaire Disposable Tourniquet Cuff, model 564008, distributed nationwide. The hazard is an incorrect expiration date, as the cuff is labeled with a 10-year shelf life but only has a validated 5-year shelf life, exposing patients to potentially ineffective or unsafe use. Consumers must check the expiration date and stop using the cuff if it is beyond the 5-year validated shelf life.
Cardinal Health Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets are affected. The handpieces may leak fluid onto the floor, posing a slip and fall hazard to users. Consumers should stop using the affected kits and contact Cardinal Health for instructions.
The recall affects McKesson CONSULT hCG Urine Cassette, Alere hCG Cassette, Fisher Scientific Sure-Vue hCG-STAT, and other hCG rapid tests. These tests may detect low hCG levels below stated sensitivity, causing false positive results for users. Consumers should stop using the affected tests
Percussionaire Corporation is recalling Travel Air (S00055) and Phasitron 5 (P5) used with the instruction manual. Using these devices with volatile anesthetic delivery systems can alter anesthesia, causing dangerous effects like abnormal heart rate, muscle tone changes, or awareness during surgery for patients. Users must follow the updated labeling warning and stop using intrapulmonary percussive ventilation with volatile anesthetic delivery systems.
Beckman Coulter AU480 Chemistry Analyzer systems with affected software are recalled. A fatal database error can stop the instrument software, delaying patient results. The firm initiated a voluntary recall.
ASP Global is recalling its Disposable Tourniquet Cuff, 34" x 4" 2-Line, Blue, model ASP-564013. The cuffs have incorrect expiration dates, showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially ineffective devices. Users should locate affected cuffs, verify expiration dates, and follow the recall instructions for return or disposal.
The recall affects MPR brand Single Use Tourniquet Cuff 30" 1 Line, model DT-7030-01Q, manufactured from September 2016 to March 2023. 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 or non-sterile devices. Consumers should stop using affected cuffs, check the expiration date, and contact the firm for replacement or return.
Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.