602 alerts recorded, refreshed every six hours. Filter by source or category.
Medline convenience kit labeled as FOOT ANKLE, SKU DYNJ65395A, is affected. The hazard is a discrepancy in the shelf-life of a component, exposing consumers who use the kit. Consumers should stop using the kit and contact Medline Industries for instructions.
Medtronic Sofamor Danek USA Inc is recalling Grafton DBM and Grafton Plus DBM bone graft products. The donor tissue tested positive for Clostridium butyricum, posing a risk of infection if implanted in patients. Consumers should stop using any unused product and return it to Medtronic.
Cook Incorporated is recalling Williams Cystoscopic Injection Needles, part number 090001-S26, used for injections into the urethra, bladder neck, and bladder wall. The female Luer lock adapter may be misaligned or improperly torqued, causing increased procedure time and inadequate treatment for patients. Patients should contact their healthcare provider to determine if their device is affected and arrange for a replacement.
The recall affects Instrumentation Laboratory's HemoslL AcuStar HIT-lgG(PF-4), part number 0009802028, an in vitro diagnostic device. The device may produce invalid calibration curves or negative mean bias up to 47% with patient samples, exposing patients to incorrect test results. The firm initiated a voluntary recall, but no consumer action is specified in the notice.
Medline surgical convenience kits, including open heart, vascular, and transplant packs with specific SKUs, are affected. The kits contain cannula components that may leak or break during use, posing a risk to patients undergoing surgery. Consumers should stop using the affected kits and contact Medline or follow the recall instructions for return or replacement.
Howmedica Osteonics Corp. is recalling its Triathlon Hinge Femoral Prep Tray, catalog number 6543-6-514. The tray may retain residual moisture after sterilization when blue wrap is used, posing a contamination risk to patients and healthcare staff. Consumers should stop using affected trays and contact the firm for revised reprocessing instructions or return.
Ferno-Washington Inc. is recalling the Power F2 Powered Fastening System used with Power X2 Stretchers. A firmware issue can cause intermittent loss of powered function, delaying patient transport for users and patients. The recall is voluntary and firm-initiated; no consumer action is specified.
Howmedica Osteonics Corp. is recalling its TS Universal Baseplate Finishing Tray, Triathlon, catalog number 6543-6-506. The tray’s sterilization dry time may leave residual moisture when blue wrap is used, potentially exposing patients to infection. Consumers should stop using the affected trays and contact the firm for return or correction.
AVID Medical, Inc. is recalling its Plastics Tray, model EURO053. The tray may be contaminated with a lubricant used during manufacturing, posing a hazard to consumers in AZ, CA, FL, MD, NE, and TX. Consumers should follow the recall instructions from AVID Medical.
Mindray is recalling operator's manuals for Passport Series Patient Monitors models 8, 12, 12M, 17M, and V. The manuals have unclear descriptions of some physiological alarm functions, which could mislead users operating the monitors. Users should obtain corrected information from Mindray or follow the firm's instructions.
AVID Medical, Inc. is recalling its Heart Prep Tray, model MECV97W. The tray may be contaminated with a manufacturing lubricant, posing a risk to patients during heart procedures. Consumers should stop using the affected trays and contact AVID Medical for a replacement or return.
AVID Medical is recalling its PACK OPEN HEART CFH kits, models UFCF004-06 and UFCF004-07. The kits may contain a manufacturing lubricant, posing a risk to patients during heart surgery. Consumers should stop using the affected kits and contact AVID Medical for return and replacement.
LeMaitre Vascular is recalling its TufTex Over-the-Wire Embolectomy Catheter, catalog number E1651-88. The balloon components may fail under pull force, posing a risk to patients during surgical procedures. Consumers should stop using the device and return it to the company for a replacement or refund.
Mindray DS USA is recalling the T1 Patient Monitor Operator's Manual. The manual may have unclear descriptions of certain physiological alarm functions, which could affect patient safety. Users should obtain the corrected manual or contact Mindray for further instructions.
DRG International, Inc. is recalling its Sperm Ab ELISA test, catalog number EIA-1826. The test may produce false negative results, which could lead to incorrect diagnosis for patients. Consumers should stop using the affected test and contact DRG International for instructions.
Intellijoint Surgical is recalling its Intellijoint Navigation System Workstation G2, HIP Cart System, and HIP Portable System (REFs 000-0241, 000-0250, 000-0249). The workstation may contain a recalled 15-inch MacBook Pro battery that can overheat, posing a fire hazard to users. Consumers should stop using the affected systems and contact Intellijoint Surgical for replacement or repair.
Quantum Ops Inc is recalling its ADAPTABLE Beach Chair surgical patient positioner, models 804-33-300 and 3105-400-030. A weak weld in the head positioning system can fail, posing injury risk to patients during surgery. Users should stop using the affected positioners and contact Quantum Ops for return or correction.
AVID Medical, Inc. is recalling its Laparoscopic Prostatectomy kit, model NIHB0036-07. The kit may be contaminated with manufacturing lubricant, posing a risk to patients undergoing the procedure. Consumers should follow the recall instructions from AVID Medical.
Mindray DS USA is recalling operator's manuals for its BeneView Series T5 and T8 monitors. The manuals have insufficient or unclear descriptions of certain physiological alarm functions, affecting users of these monitors worldwide. Consumers should contact Mindray DS USA to receive corrected manuals.
Mindray DS USA is recalling the operator's manuals for its cPM 8 and cPM 12 patient monitors. The manuals have unclear or insufficient descriptions of certain physiological alarm functions, which could lead to incorrect use and put patients and healthcare providers at risk. Users should stop using the affected manuals and obtain the corrected version from Mindray.
The affected products are Beckman Coulter DxC 500 AU Clinical Chemistry Analyzers, part numbers C63519 and C63520. A software issue can silently revert test units to default settings, causing falsely elevated plasma test results for patients. Users should contact Beckman Coulter for guidance on correcting the configuration.
Canon Medical System USA is recalling its Alphenix INFX-8000C/B5 imaging system. Loose bolts in the longitudinal movement mechanism can shift the tabletop, causing misalignment and motion errors for patients and operators. Users should stop using the affected system and contact Canon Medical for inspection and repair.
The HALYARD Laparoscopy Comprehensive Pack II REF 49332, made by GRI Medical & Electronic Technology Co., Ltd., is affected. The packs are labeled "latex free" but contain a latex urethral catheter, exposing patients with latex allergies to a hazard. The firm initiated a voluntary recall of the affected packs.
AVID Medical, Inc. is recalling its Endovascular Pack, model VAPX014-04. The product may be contaminated with a manufacturing lubricant, posing a risk to patients and healthcare workers in Arizona, California, Florida, Maryland, Nebraska, and Texas. Consumers should stop using the affected kits and follow the firm's recall instructions for return or replacement.
Mindray DS USA is recalling operator's manuals for BeneVision Series Telemetry Monitors TM70 and TM80. The manuals have unclear descriptions of certain physiological alarm functions, which could lead to incorrect monitoring for patients. Consumers should review the corrected manual or contact Mindray for updated instructions.
AVID Medical, Inc. is recalling its DAVINCI LAP/GYN kit, model WRNM037-16. The product may be contaminated with manufacturing lubricant, posing a risk to patients in AZ, CA, FL, MD, NE, and TX. Consumers should stop using the affected kit and contact AVID Medical for return instructions.
The recall affects SEDIPLAST tubes, models S-100 and S-1000, from Polymedco, Inc. and Polymedco Cancer Diagnostic Products, LLC. During use, increased resistance when inserting the pipette can cause the cap to detach and release blood, exposing the operator and work area to a biological hazard. Consumers should stop using the affected tubes and contact the company for further instructions.
Beckman Coulter is recalling its DxC 500i Clinical Analyzer Modules, including part numbers C63522, C63521, and C13252. A software issue can revert configured test units to default without warning, causing falsely elevated results for patients whose plasma samples are tested. Users should follow the firm's recall instructions and contact Beckman Coulter for correction.
Cardinal Health 200, LLC is recalling Presource Packs containing Medtronic Microstream Components, including specific intubation and intubating bag kit catalog numbers. The hazard is difficulty disconnecting the adapter from the patient's endotracheal tube, which can delay treatment, cause unintended extubation, and lead to respiratory failure, hypoxia, aspiration, or low oxygen saturation. Consumers should follow the firm's voluntary recall instructions for the affected kits.
Mindray DS USA, Inc. is recalling operator's manuals for its Panorama and Telemetry Monitoring System, including TMS-6016, Panorama Telepack-608, and TMS60 (TD60). The manuals have insufficient or unclear descriptions of selected physiological alarm functions, which could affect patients and healthcare users relying on the system. Consumers should contact Mindray DS USA, Inc. for corrected manual instructions.
The affected product is the AVID Medical MAJOR PACK, model NIHB0018-11. The device may be contaminated with a manufacturing lubricant, posing a risk to patients and users in AZ, CA, FL, MD, NE, and TX. Consumers should stop using the product and follow the firm's recall instructions for return or disposal.
Medical Action Industries is recalling its Urinary Clean Catch Kit, model 76769, lot 333606. The kit’s label shows an incorrect expiration date of March 31, 2027, instead of February 28, 2027, which may lead to use after the true expiry. Consumers who have lot 333606 should stop using the kit and contact Medical Action Industries for instructions.
AVID Medical, Inc. is recalling its GYN LAPAROSCOPY/LAPAROTOMY kits, models WRNM002-15 and FBCH108-03. The kits may be contaminated with a manufacturing lubricant, posing a risk to patients. Consumers should stop using the affected kits and contact AVID Medical for instructions.
Mindray DS USA is recalling its BeneVision N1 and N-Series patient monitors, models N12, N15, N17, N19, and N22. The operator's manuals lack clear descriptions of certain physiological alarm functions, which could lead users to miss or misinterpret alarms, affecting patient safety. Users should review the corrected manual provided by the firm or contact Mindray for instructions.
AVID Medical, Inc. is recalling its ABD HYSTERECTOMY kit, model NAMC438-07. The kit may be contaminated with a lubricant used during manufacturing, posing a risk to patients in AZ, CA, FL, MD, NE, and TX. Consumers should stop using the kit and contact AVID Medical for instructions.
AVID Medical, Inc. is recalling its GYN LAPAROSCOPY PACK, model NAMC436-12. The kit may be contaminated with a lubricant from manufacturing, posing a risk to patients during gynecologic laparoscopy. Consumers should stop using the affected kit and contact AVID Medical for instructions.
Medline Industries is recalling its Bariatric Basic Steel Burgundy rollator, model MDS86800XWS. The front wheel assembly may detach, causing falls and severe injuries such as head trauma or bone fractures for users. Consumers must stop using the rollator if the front wheels become loose or detach.
Steris Corporation is recalling its VERIFY Biological Steam Test Pack, model S3069. The spore population may be too low, causing a false pass for steam sterilization and exposing patients to improperly sterilized equipment. Consumers should stop using the affected test packs and contact Steris for instructions.
AVID Medical, Inc. is recalling its DAVINCI TRUCUSTOM BUNDLE kits, model numbers SAMM064-27 and SAMM064-28. The kits may be contaminated with a lubricant from manufacturing, posing a risk to patients or users. Consumers should stop using the affected kits and contact AVID Medical for return or replacement.
Mindray DS USA is recalling its ePM Series Patient Monitors, including models ePM 10M, 12M, 12MA, 15M, and 10A. The operator's manuals have insufficient or unclear descriptions of selected physiological alarm functions, which could affect patient safety. Consumers should contact Mindray DS USA to obtain corrected operator manuals.
AVID Medical, Inc. is recalling its UROLOGY MAJOR kit, model WRNM058-10. The kit may be contaminated with a lubricant used during manufacturing, posing a risk to patients in AZ, CA, FL, MD, NE, and TX. Consumers should stop using the kit and contact AVID Medical for return and replacement instructions.
The affected product is the Steris Corporation HexaVue Focus Integration System, software version 2.0.18. A software issue may cause incorrect patient information on manually printed images, leading to documentation errors for patients and healthcare providers. Consumers should contact Steris Corporation for recall instructions.
AVID Medical, Inc. is recalling its Craniotomy Pack, model WRNM035-20. The kit may be contaminated with manufacturing lubricant, posing a risk to patients undergoing surgery. Consumers should stop using the affected kit and contact AVID Medical for instructions.
The recall affects Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M. The implants were inadvertently mixed up and distributed to incorrect customers, exposing patients in North Carolina and California to potential surgical mismatch. Consumers should contact their healthcare provider to determine if their implant is affected and seek guidance.
AVID Medical, Inc. is recalling its Adult Heart Tray Shands Jacks, model SHND419-08. The product may be contaminated with a manufacturing lubricant, posing a risk to patients during heart procedures. Consumers should stop using the affected kit and contact AVID Medical for return instructions.
Steris Corporation is recalling its VERIFY Biological/Integrator Challenge Pack, model LCB007. The spore population may fall below specification, causing false negative results in steam sterilization monitoring, exposing users to potentially unsterile instruments. Consumers should stop using affected packs and contact Steris for instructions.
AVID Medical, Inc. is recalling its Robotic Prostatectomy Pack, model NAMC423-11. The pack may be contaminated with a lubricant used during manufacturing, posing a risk to patients. Consumers should stop using the affected pack and contact AVID Medical.
Steris Corporation's VERIFY Dual Species Self-Contained Biological Indicator Model S3060 is affected. The spore population may fall below specification, causing false sterilization results for users monitoring steam cycles. Consumers should follow the recall instructions provided by Steris Corporation.
Limitless Cryo Spa LLC is recalling its Glypto Device and Glypto Cryo Machine. The devices lack required FDA 510(k) clearance, posing a safety risk to users nationwide. Consumers should stop using the devices and contact Limitless Cryo Spa LLC for instructions.
Steris Corporation is recalling its VERIFY Dual Species Self-Contained Biological Indicator, model S3061. The spore population may fall below specification, causing a false pass in steam sterilization monitoring, affecting users worldwide. Consumers should stop using affected units and contact Steris Corporation for instructions.
Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.