602 alerts recorded, refreshed every six hours. Filter by source or category.
Hollister is recalling its Onli 17cm Hydrophilic Urethral Intermittent Catheter, including multiple SKU/REF numbers. A manufacturing defect can cause a protrusion that may lead to genitourinary trauma or bleeding in users. Consumers should stop using the affected catheters and follow the recall instructions.
Medline Industries is recalling its medical convenience kit labeled as TRACH TUBE KIT, SKU DYKM2330. The hazard is a component labeling discrepancy, affecting users of the kit. Consumers should consult the FDA recall notice for the required action.
Medline Industries is recalling multiple convenience kits, including Major Gyn Pack, Open Heart Pack, and others, with specific SKUs. The kits contain a potentially contaminated component, exposing patients and users to risk. Consumers should refer to the FDA recall notice for instructions.
GE Medical Systems Information Technologies Inc is recalling PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592. The software issue may cause loss of patient monitoring and reset alarm settings, putting patients at risk. Consumers should contact the firm for instructions or updates.
GE Medical Systems' Portrait Core Services Software V1.0.5, Ref# 5697353, is recalled. The hazard is loss of patient monitoring and reset alarm settings, exposing patients in the US and other listed countries. Users should contact GE Medical Systems for instructions.
American Contract Systems Inc is recalling its Convenience Kit, D & C PACK, model LLPD90H. The kit contains Medline red rubber catheters that failed performance specifications, posing a risk to patients using them. Consumers should stop using the affected kits and contact American Contract Systems Inc for instructions.
AVID Medical, Inc. is recalling Halyard TOTAL JOINT Model/Catalog Number MSBM036-03 medical kits. The kit's labeling fails to identify that the statlock component contains natural rubber latex, posing a risk to people with latex allergy. Consumers should stop using the recalled kit and contact AVID Medical, Inc. for instructions.
The recall affects Halyard DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK, model SAMM064-27. The kit's labeling fails to identify that the statlock component contains natural rubber latex, which can harm people with latex allergy. Consumers should contact AVID Medical for instructions on returning or replacing the affected kit.
Medline Industries is recalling its convenience kits labeled LTP CDS-LF, SKU CDS980375M, distributed nationwide in several states. The kits contain a potentially contaminated component, exposing users to a health risk. Consumers should stop using the recalled kits and follow the firm's recall instructions.
AVID Medical, Inc. is recalling Halyard TOTAL JOINT Model/Catalog Number MSBM036-03 medical kits. The labeling fails to identify that the statlock component contains natural rubber latex, posing a risk to people with latex allergies. Consumers should follow the recall instructions from AVID Medical.
Medline Hudson RCI breathing circuit, product number HUD78019 (Teleflex 780-19), is affected. The heated wire connector may overheat, causing smoke or melting, which can lead to airway obstruction and respiratory distress in infants. Consumers should contact Medline Industries for further instructions.
Medline is recalling certain medical convenience kits labeled as sinus, ENT, head and neck, and transsphenoidal packs with specific SKU numbers. The kits contain neurosponges with potentially unsafe endotoxin levels, posing a risk to patients during procedures. Consumers should stop using the recalled kits and contact Medline for instructions on returning them.
Canon Medical Systems is recalling Alphenix models INFX-8000C, INFX-8000F, and INFX-8000V digital radiography/fluoroscopy systems. The ceiling movement gear screws may become loose, posing a risk to patients and staff during procedures. Consumers should contact Canon Medical Systems for instructions on inspection and repair.
Merge Healthcare, Inc. is recalling Merge PACS and Merge OrthoPACS medical imaging diagnostic workstations. The software may display inaccurate measurements, posing a risk to patients whose diagnoses rely on these images. Consumers should contact Merge Healthcare or their healthcare provider for instructions on updating or correcting the software.
Fresenius Medical Care is recalling its 2008T BlueStar Hemodialysis Machine, model numbers 191126 and 191130. The machine may trigger flow, no-water, or temperature alarms, exposing patients to treatment interruptions or harm. Consumers should follow the recall instructions and contact Fresenius Medical Care for guidance.
Olympus Corporation is recalling its POWERSEAL 5 mm 23 cm Curved Jaw Sealer & Divider electrosurgical device. The outer shelf box may be incorrectly labeled as a 37-cm device, posing a risk to patients and healthcare providers. Consumers should contact Olympus Corporation to return the affected device or receive instructions.
Medline Industries is recalling C-section convenience kits with SKUs DYNJ904612L, DYNJ911755, and DYNJ912014. Users of these kits may be exposed to a potentially contaminated component. Consumers should stop using the affected kits and follow the recall instructions.
IMRIS Imaging Inc is recalling its ORT300 operating room table, including Modular Table Main Unit Assy part numbers 114093-000 and 114093-600. The linear actuator and rotational lock can fail, causing unintended table movement and possible injury to patients during procedures. Consumers should contact IMRIS Imaging Inc for instructions on returning or servicing the affected tables.
Medline Industries is recalling Hudson RCI heated wire breathing circuits used for neonatal and infant care. The heated wire connector can overheat, causing smoke or melting, and may lead to airway obstruction or breathing distress in infants. Consumers should stop using the affected circuits and contact Medline Industries for instructions.
IMRIS Imaging Inc is recalling its ORT200 operating room table, including reconditioned covered table assemblies with part numbers 113821-600 and 114148-000. The linear actuator and rotational lock can fail, causing unintended table movement that may injure patients during procedures. Consumers should contact IMRIS Imaging Inc for instructions.
Medline convenience kits labeled Major Procedure, Operative Lap P&S Surgical, and Laparoscopy (SKUs CDS982040U, DYNJ89608, DYNJ903479L, DYNJ903479M) are affected. The kits contain a potentially contaminated component, exposing patients to infection risk. Consumers should stop using the kits and contact Medline for instructions.
Medline Industries is recalling four convenience kits, including CMH Litho Minor Pack-LF and GYN Laparotomy, sold nationwide. The kits contain a potentially contaminated component, exposing patients to risk of infection. Consumers should stop using the affected kits and contact Medline for return or replacement.
Medline Industries is recalling four convenience kits labeled LAMI FUSION, NON MB MJR NEURO CRANI SM PK, CRANIOTOMY, and KIT CRANIOTOMY RFD with specific SKUs. The kits contain a potentially contaminated component, exposing patients who use them to risk. Consumers should stop using the recalled kits and follow Medline's recall instructions.
Dentsply Sirona Capsule Mixer Model No. 5546068 is recalled. The unit may cause electrical discharge when unplugged, exposing users to shock. Consumers should stop using the mixer and contact Dentsply Sirona.
The recalled product is the Getinge Y Sensor Module, model 6693662, used in SERVO-U and SERVO-N continuous ventilator systems for facility use. The module skipped electrical safety and functional tests during production, exposing patients and staff to potential device failure. Consumers should contact Maquet Critical Care for instructions on returning or replacing the affected module.
Arrowhead DE LLC's Arrow-LOK Implant is affected. The implant may have reduced sterility assurance due to a missing gamma radiation dose audit, which could lead to patient infection in those undergoing toe fixation procedures. Consumers should follow the voluntary recall initiated by the firm.
Tobii Dynavox is recalling its TD Navio Maxi Speech Generating Device, model 1000799. Damaged battery mounting tabs can let the battery move and cause an internal short circuit, leading to localized heating and gas venting for users. Consumers should contact Tobii Dynavox for instructions.
Beckman Coulter DxC 500i Clinical Analyzer Modules and DxC 500 AU Clinical Chemistry Analyzers using software version 1.5 or lower are affected. A software defect can silently overwrite user-customized calculated test rules, potentially generating erroneous patient test results without error notification. The recall is voluntary and firm-initiated.
Gentherm Medical, LLC is recalling its Innercool Coolblue Console, Model STx, a thermal regulating system. Overheating of the 115V CPU board may cause the device to shut down, exposing patients to risk. The recall is voluntary and firm-initiated.
Fort Defiance Industries (FDI) is recalling its Automated Field Steam Sterilizer, REF P2131. The water recovery system's 120V Amphenol connector can lose ground continuity, creating an unreliable fault current return path that exposes users to electrical shock. Consumers should stop using the sterilizer and contact Fort Defiance Industries for instructions.
The recall affects the Blanketrol III, Model 233 thermal regulating system made by Gentherm Medical, LLC. Overheating of the 115V CPU board can cause the device to shut down, exposing patients to risk. Consumers should contact Gentherm Medical for instructions.
The recall affects the Boston Scientific ENROUTE Transcarotid Neuroprotection System, material number SR-200-NPS, a percutaneous catheter. The hazard is possible arterial sheath tip separation during use, exposing patients to serious injury. Consumers should stop using the affected device and contact Boston Scientific for instructions.
Beckman Coulter DxC 500 AU Clinical Analyzer Modules with software version 1.5 or lower are affected. A software defect can silently revert user-customized calculated test rules to defaults when importing a new Parameter Package, potentially causing erroneous patient test results. Users should contact Beckman Coulter or follow the recall instructions to correct the issue.
Bard Access Systems, Inc. (BD) is recalling its BD Needle Kit for Powered Driver in 15mm, 25mm, 35mm, 45mm, and 55mm sizes. The obturator may lock to the needle hub, making removal difficult and causing delayed therapy for patients needing intraosseous access. Consumers should stop using the affected kits and contact the firm for return or replacement.
Medtronic MiniMed's MiniMed 640G Insulin Pump models MMT-1711 and MMT-1712 are affected. Loaner pumps cleaned with incompatible products may damage the case or keypad, allow moisture in, and cause over- or under-delivery of insulin, leading to hypoglycemia, hyperglycemia, or diabetic ketoacidosis for users. Consumers should contact Medtronic MiniMed for instructions.
Spectral Instruments Inc is recalling the Ami HTX device. The device may momentarily fail to show the "X-Ray On" banner during a readiness check, exposing patients and operators to unintended radiation. Consumers must follow the FDA-mandated recall instructions for this device.
The recall affects Medtronic MiniMed 670G Insulin Pump models MMT-1781 and MMT-1782. The hazard is that loaner pumps may have been cleaned with incompatible products, damaging the case or keypad and allowing moisture ingress, which could cause insulin over- or under-delivery and lead to hypoglycemia, hyperglycemia, or diabetic ketoacidosis. Consumers should follow the recall instructions from Medtronic MiniMed.
Spectral Instruments Inc's Lago X device is affected by this recall. The hazard is a momentary absence of the on-screen X-Ray On banner during a run readiness check, which could expose patients and operators to unintended radiation. Consumers should follow the FDA recall notice for instructions.
Boston Scientific's ENROUTE Transcarotid Neuroprotection System Plus, material number SR-250-NPS, a percutaneous catheter, is affected. The hazard is potential arterial sheath tip separation during use, affecting patients worldwide including the US, Australia, Canada, China, and Jamaica. Consumers should contact their healthcare provider or Boston Scientific for instructions on returning the device.
Paragon 28, Inc. recalled its Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, model 6123N R, a foot implant. The implant has elevated oxygen levels above the allowable limit, which may reduce material ductility, exposing patients to potential device failure. Consumers should follow the firm's voluntary recall instructions for this nationwide-distributed product.
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen (REF L2KSY2(D)/10471981) is affected. The assay may show a negative bias, causing low reactive syphilis results to be reported as nonreactive for patients tested. Consumers should contact their healthcare provider to discuss their results and possible retesting.
ConvaTec is recalling its Esteem Body Soft Convex Urostomy Pouch models 423703 through 423727. The pouches may leak from the cap during use, affecting patients who use them. Consumers should stop using the affected pouches and contact ConvaTec for instructions.
Philips North America is recalling the Cardiac Workstation 7000, product number 860441. The device may intermittently provide inaccurate native heart rate data, affecting patients worldwide. Consumers should contact Philips North America for instructions.
The recall affects BMC Medical Co., Ltd. and React Health Luna G3 APAP REF LG 3600 devices distributed in Florida. The recall was initiated due to a rework issue at the warehouse, and patients using the device are potentially exposed. Consumers should stop using the device and contact the firm for instructions.
Covidien is recalling its EndoFLIP System, including the EF-100 and refurbished RFG-EF100 units and catheter components. The system's 24-hour usage limit incorrectly flags catheters as expired, making them unavailable for clinical procedures, affecting patients and healthcare providers worldwide. Consumers should stop using affected devices and contact Covidien for replacement or further instructions.
Paragon 28, Inc. recalled its Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, model 6123S R, a foot implant. The implant has elevated oxygen levels that may reduce material ductility, posing a risk to patients who received it. Consumers should contact their healthcare provider to determine if they have the affected implant and what steps to take.
Boston Scientific is recalling its Suture Cinch Long 1pk endoscopic tissue approximation device. The device may fail to deploy the cinch implant or cut the suture, posing a risk to patients undergoing endoscopic procedures. Consumers should stop using the affected device and contact Boston Scientific for further instructions.
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen is affected. The assay may report low reactive syphilis results as nonreactive, exposing patients to false negative results. Consumers should contact their healthcare provider to discuss whether retesting is necessary.
Philips North America LLC is recalling the Cardiac Workstation 5000, product number 860439. The device may intermittently provide inaccurate native heart rate data, affecting patients and users worldwide. Consumers should contact Philips North America for further instructions.
The affected product is the Medtronic MiniMed 780G Insulin Pump, models MMT-1885CLW and MMT-1886CLW. Users of these loaner pumps may face incorrect insulin delivery due to chemical damage from cleaning, risking hypoglycemia, hyperglycemia, or diabetic ketoacidosis. Consumers should contact Medtronic MiniMed for instructions on returning or replacing the affected pump.
Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.