602 alerts recorded, refreshed every six hours. Filter by source or category.
Steris Corporation is recalling RAPICIDE PA Part A High-Level Disinfectant, model ML020116. A blocked vented cap can cause gas buildup and bottle swelling, and escaping vapor or liquid may injure users or nearby people if protective equipment is not worn. Consumers should stop using the affected product and contact Steris Corporation for instructions.
Neuronetics is recalling its NeuroStar Advanced Therapy System with the NeuroStar HP Coil Assembly part number 81-01000-200. The cables do not meet product specifications, posing a hazard to patients using these systems in the US, Japan, and South Korea. Consumers should contact Neuronetics for instructions.
Medline surgical convenience kits for ear and carotid procedures, including SKUs DYNJ909020B, DYNJ909020A, DYNJ42922C, DYNJ909020, DYNJ65706, and CDS983139B, are affected. The kits contain cannula components that do not meet dimensional requirements and may leak or break during use, exposing patients and healthcare workers to risk. Consumers should stop using these kits and contact Medline for return or replacement.
Boston Scientific is recalling its NaviFlex LW Pusher and Advx Panc. Stent 4/5F, material number M00535030. The device was incorrectly manufactured with a guidewire exit port, which is not a design feature and may affect patients during use. Consumers should follow the recall instructions from Boston Scientific.
BioFire Diagnostics' FilmArray Pneumonia Panel, including catalog numbers RFIT-ASY-0144, RFIT-ASY-0145, and verification kit FLM1-ASY-0150, is affected. Specific lots may be contaminated, causing false positive results for patients tested with these panels. Consumers should check their lot numbers and contact BioFire Diagnostics for recall instructions.
Howmedica Osteonics Corp. is recalling its TS Misc. Instruments Tray, Triathlon, catalog number 6543-6-519. The hazard is residual moisture after sterilization when blue wrap is used, which can affect patients. Consumers should stop using affected trays and contact the firm or distributor for return instructions.
Becton Dickinson & Co. is recalling BD Phoenix Panel NMIC-306, catalog number 449292. The panel may cause quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature, affecting users nationwide. Users should comply with the firm's voluntary recall.
The recall affects the JenaValve Trilogy Delivery Catheter, Size 23MM, made by JenaValve Technology Inc. The catheter's sleeve liner may separate, making it hard or impossible to deploy the heart valve, posing a risk to patients during the procedure. Patients and healthcare providers should stop using the affected catheters and contact JenaValve Technology for return and replacement instructions.
Medline Industries convenience kits containing CONMED AirSeal Access Ports are recalled. The ports can cause erroneous overpressure alerts and system venting during laparoscopic procedures, leading to delays or early termination, affecting patients. The recall is voluntary and firm-initiated, so consumers should follow the recall instructions.
Medline Industries is recalling its surgical convenience kits labeled as CABG AUXILIARY PACK with product number DYNJ44925D. 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 for instructions.
The affected product is the Merit Medical Systems Scout MD delivery system, models MDS05A-01, MDS05C-01, and MDS10C-01. The implantable clip may fail to deploy, preventing the reflector from working, which affects patients in Arizona, California, Florida, Indiana, Louisiana, Nevada, and Rhode Island. Consumers should consult the FDA recall notice for further instructions.
Healthmark Industries is recalling its Vinyl Instrument Guards, including all vented guard models. The hazard is noncompliant labeling and updated steam sterilization instructions, affecting anyone using these guards. Consumers should follow the updated steam sterilization instructions.
Becton Dickinson & Co. is recalling its BD Phoenix Panel NMIC-312, catalog number 449082. The panel may cause quality control failures with Klebsiella pneumoniae, exposing laboratories and patients to inaccurate test results. Users should stop using the affected panels and follow the firm's voluntary recall instructions for return.
Medline Industries is recalling convenience kits containing CONMED AirSeal Access Ports. The ports can produce erroneous overpressure alerts and vent the system during use, which may delay or end procedures, exposing patients to risk. Consumers should follow the firm's voluntary recall instructions.
The Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT, is recalled. Affected kits contain a pediatric nasal cannula instead of the intended adult one, which may not fit adult patients properly. Consumers should stop using the recalled kits and contact Sarnova HC, LLC for a replacement.
Medline Industries convenience kits containing CONMED AirSeal Access Ports are affected. The ports may give erroneous overpressure alerts and vent during use, risking procedure delays or termination for patients. Consumers should check the FDA recall notice for instructions on affected kits.
Medline Industries is recalling multiple medical convenience kits, including open heart, AV shunt, cath lab, and cardiac surgery packs, with specific SKU numbers. The kits contain cannula components that may leak or break during use, posing a risk to patients undergoing these procedures. Consumers should stop using the affected kits, check the SKU numbers, and follow Medline's return instructions.
BioFire Diagnostics is recalling its FilmArray Pneumonia Panel plus kits, models RFIT-ASY-0143 and RFIT-ASY-0142. Contaminated lots may cause false positive results, affecting patients tested with these panels worldwide. Consumers should contact their healthcare provider to discuss their test results and any needed retesting.
Integrated Medcraft LLC is recalling its FORWARD Gunshot Wound Kit, model AFT-GSW. The sterile pad inside the kit may degrade over time, leaving nonwoven material remnants on or near a wound, posing a risk to patients. Consumers should stop using the affected kit and contact the firm for instructions.
Steris Corporation is recalling RAPICIDE PA Part A High-Level Disinfectant, model ML020117. A blocked vented cap can cause gas buildup and bottle swelling, leading to vapor or liquid escape during opening and exposure to users or people nearby if PPE is not properly used. Consumers should stop using the recalled product and contact Steris Corporation for instructions.
Medline Industries is recalling multiple surgical convenience kits, including vein harvesting, vascular, and AV fistula packs, sold under the Medline brand. The kits contain cannula components that do not meet dimensional requirements and may leak or break during use, posing a risk to patients undergoing procedures. Consumers should check the FDA recall notice and follow its instructions for the affected kits.
Ethicon's PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, product code N271H, is affected. The sutures are packaged with an alcohol-based fluid that can reduce suture strength, cause tissue irritation, and lead to treatment failure or bleeding, affecting patients in cardiovascular, ophthalmic, and neurological procedures. Consumers should check sutures for the fluid before use and not use any that contain it.
The recall affects the JenaValve Trilogy Delivery Catheter, Size 25MM, from JenaValve Technology Inc. The catheter's sleeve liner may separate, making it difficult or impossible to deploy the heart valve, posing a risk to patients during the procedure. Consumers should contact their healthcare provider about the recall.
The GORE VIABIL Short Wire Biliary Endoprosthesis, models VSWVH0808 and VSWVN1006, is affected. The devices may be mislabeled with the incorrect length, which affects patients who receive them. The recall notice does not specify a consumer action.
Microgenics Corporation is recalling its MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, including sample packs. The affected lot has vial-to-vial variability causing low parathyroid hormone recovery, which may delay patient PTH results. Laboratories should stop using the recalled lot and follow the firm's instructions for return or disposal.
Steris Corporation's RAPICIDE PA Part A High-Level Disinfectant, model ML020115, is affected. A blocked vented cap can cause gas buildup, bottle swelling, and escape of vapor or liquid, exposing users or nearby people to injury if PPE is not used. Consumers must properly use required personal protective equipment when opening the bottle.
The recall affects the JenaValve Trilogy Delivery Catheter, Size 27MM, from JenaValve Technology Inc. The catheter's sleeve liner may separate, making it hard or impossible to deploy the heart valve, putting patients at risk during the procedure. Patients should contact their healthcare provider or the company to determine if their device is affected and what to do next.
Beckman Coulter is recalling its IQ200 SPRINT, SELECT, and ELITE devices. The rinse-line check valve can leak lamina fluid, causing slip/fall, chemical or biohazard exposure, property damage, and delayed patient results for users and patients. Users should contact Beckman Coulter to schedule annual replacement of the check valve.
Medline surgical convenience kits, including spinal, custom crani, and other packs with specific SKUs, are affected. The kits contain cannula components that do not meet dimensional requirements and may leak or break during use, exposing patients to risk. Consumers should stop using the affected kits and contact Medline for instructions.
In2bones USA, LLC is recalling its REF P65 ST862 CoLag Screw, FT, 6.7x62.5 mm bone screws. The screws are labeled as fully threaded but are actually partially threaded, exposing patients to potential surgical complications. Consumers should contact their healthcare provider or In2bones for instructions on returning or replacing the affected screws.
SI-BONE, Inc. is recalling its iFuse TORQ Implant System in specific sizes. The pelvic fixation screws may not be sterile because the tube packaging seal failed, affecting patients who receive these implants. Consumers should contact their healthcare provider or SI-BONE for instructions.
The recalled product is the Cadwell Industries IOMAX Cortical Module, model 190296-200. A defective circuit board can cause unintended electrical stimulation or current to reach patients. Consumers should contact Cadwell Industries for instructions.
Radiometer Medical ApS is recalling its ABL90 FLEX and ABL90 FLEX PLUS analyzers. The devices may produce potentially inaccurate results, posing a risk to patients whose tests are ordered by physicians. Users must follow the revised instructions for use and contact the firm for further guidance.
Medline Industries is recalling Convenience Kits containing CONMED AirSeal Access Ports, model KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G. The ports can give erroneous overpressure alerts and vent during use, which may delay or end procedures for patients. Consumers should stop using the kits and contact Medline or CONMED for return instructions.
Medline surgical convenience kits labeled CV BASIN PACK-LF with SKUs DYNJ0538615K, DYNJ0538615J, and DYNJ0538615L are affected. The kits contain cannula components that may leak or break during use, exposing patients to risk. Consumers should stop using the affected kits and contact Medline for instructions.
Howmedica Osteonics Corp. is recalling the TS Femoral Prep Tray, Triathlon, catalog number 6543-6-507. Trays sterilized in blue wrap with a 30-minute dry time may retain residual moisture, exposing surgical staff and patients to infection risk. Consumers should immediately stop using affected trays and follow the firm's recall instructions for return or reprocessing.
Intelerad Medical Systems is recalling IntelePACS and InteleConnect Portal/Tech Portal software versions listed in the recall notice. The hazard is that after using a Chromium-based web browser, the report and displayed images may not match, affecting users nationwide. Consumers should contact Intelerad Medical Systems for instructions on correcting the issue.
Instrumentation Laboratory's HemosIL AcuStar HIT-IgG(PF-4), part number 0009800127, an in vitro diagnostic device, is affected. The hazard is a potential invalid calibration curve or negative mean bias of up to 47% with patient samples, exposing patients to incorrect test results. The firm initiated a voluntary recall of this product.
The recall affects BioFire Diagnostics Joint Infection (JI) Panel kits, models RFIT-ASY-0138 and RFIT-ASY-0135. Certain lots may be contaminated, causing false positive results for patients tested for joint infections. Consumers should stop using affected kits and contact BioFire Diagnostics or their healthcare provider 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 return any unused product to Medtronic for retrieval.
Medline surgical convenience kits, including MAIN/LAPAROSCOPY TRANSPLA PACK and CATH LAB ENDO AAA, are affected. The cannula components may leak or break during use, posing a risk to patients. Consumers should stop using the affected kits and contact Medline for instructions.
Medline surgical convenience kits, including OPEN HEART, CABG, and vascular 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 for instructions on return or replacement.
Medline is recalling two surgical convenience kits: NEURO-SPINE BASIN PACK (DYNJ80055A) and AV SHUNT PACK-LF (DYNJ24528M). The kits contain cannula parts that may leak or break during use, posing a risk to patients. Consumers should stop using the affected kits and contact Medline for instructions.
Medline Industries is recalling convenience kits containing CONMED AirSeal Access Ports used in robotic surgeries. The ports may trigger false overpressure alerts and vent during use, risking procedure delays or stoppage for patients and surgical staff. Consumers should stop using affected kits and contact Medline Industries for return or replacement instructions.
Beckman Coulter is recalling its DxU 840m Iris and DxU 850m Iris devices. The rinse-line check valve may leak lamina fluid, causing slip/fall, chemical or biohazard exposure, property damage, and delayed patient results. Users must ensure the check valve is replaced annually to prevent leakage.
Baxter Healthcare Corporation is recalling its Likorall Overhead Lifts, including models LIKORALL 200, 242, 243, and 250. The motor shaft may break and the Single Fault Safety system may underperform, causing the lift strap to lower faster than expected and putting patients at risk of injury from a fall. The recall is voluntary and firm-initiated, and no consumer action is specified in the notice.
Magellan Diagnostics is recalling the LeadCare II Blood Lead Test Kit, model 70-6762. The incorrect expiration date may cause the system to block testing, leading to delayed blood lead results for patients. Consumers should verify the lot number and expiration date on their kit and contact Magellan Diagnostics for a replacement.
Medline Industries is recalling its surgical convenience kits labeled VEIN HARVESTING PACK, product number DYNJ51845D. The kits contain cannula components that do not meet dimensional standards and may leak or break during use, posing a risk to patients. Consumers should stop using the affected kits and contact Medline for instructions.
Medline Industries is recalling surgical convenience kits labeled OPEN HEART with product number DYNJ902898D. The kits contain cannula components that may leak or break during use, posing a risk to patients. Consumers should stop using the affected kits and contact Medline Industries for instructions.
Medline Industries convenience kits containing CONMED AirSeal Access Ports (models DYNJ911135A and DYNJ906731M) are affected. The ports can give erroneous overpressure alerts and vent during use, which may delay or end procedures, exposing patients to risk. Consumers should stop using these kits and follow Medline's recall instructions for return.
Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.