602 alerts recorded, refreshed every six hours. Filter by source or category.
The recall affects the Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector, model CD-B622LA. The ceramic tip may detach because the device was made without the required adhesive, exposing patients to injury during use. Consumers should follow the recall instructions.
Medline Industries, LP is recalling Convenience kits CATARACT PACK DYNJ59881A. The kits may have open seals in sterile pouch packaging, which can compromise sterility and lead to contamination or patient infection if used. Consumers should stop using the affected kits and contact Medline Industries.
Bard Access Systems is recalling DuoGlide and Niagara short-term dialysis catheters. The Class I recall means the devices may cause serious injury or death to patients. Consumers should stop using the affected catheters and follow the firm's recall instructions.
The recall affects Maquet Cardiopulmonary's Percutaneous Insertion Kit (PIK), dilator set L, model numbers 701054427 (USA and OUS). The packaging may not maintain a sterile barrier, exposing patients to infection risk during use. Consumers should stop using the kits and contact the firm for instructions on return or replacement.
Medical Action Industries is recalling its Blood Culture Collection Venipuncture Kit, Blood Culture Kit, and Blood Culture Collection Kit, all containing BD ChloraPrep Clear 1 mL Applicators. An open or incomplete seal on the applicator packaging may break the sterile barrier, risking localized skin or soft tissue infection for patients. Consumers should check whether their kit is affected and follow the firm's recall instructions.
Nuclein LLC's DASH Rapid PCR Instrument, model SG-0002, with software versions 6.0.2, 6.0.4, 6.0.5, and 6.0.6, is affected. A software issue poses a hazard to users and patients. Consumers should follow the recall notice from Nuclein LLC.
The recall affects Stryker Sustainability Solutions' REF:2B5LT Ethicon XCEL Bladeless Trocar with OptiView Technology and Sleeve, 5mm x 100mm. The reusable access port system may crack or separate during use, exposing patients and healthcare workers to injury. Consumers should stop using the affected product and follow the firm's recall instructions.
ICU Medical is recalling its CADD Yellow Medication Cassette Reservoir with NRFit connector. The reservoirs may leak at the luer connector joint, causing therapy delay, underdelivery, exposure to toxic agents, or air embolus for patients. Consumers should stop using affected reservoirs and contact ICU Medical for instructions.
embecta Medical II LLC is recalling EWO_02513 (Catalog number 320122) Nano Un-Cannulated Demo Samples, quantity 100. The pen needles were labeled for investigational use only but were mistakenly sold as commercial devices, exposing patients to unapproved products. Consumers who have these samples should stop using them and contact embecta Medical II LLC for instructions.
Howmedica Osteonics Corp. is recalling its Axle Pin Assembly Large Elbow Cobalt Chrome implant, catalog number C-M112-2-500, made from UHMWPE. The affected devices may have elevated oxidation from aged raw material, causing increased wear, debris, fracture, or disassociation, leading to revision surgery, pain, and inflammation for patients. Consumers should contact their healthcare provider to determine if their implant is affected and what to do next.
The recall affects the Aisys Datex-Ohmeda anesthesia system, part number 1011-9050-000. The system may automatically switch to Alternate O2 control, interrupting anesthetic delivery and requiring clinician intervention; without it, patients may get reduced anesthetic effect. Users should contact Datex-Ohmeda for corrective action.
restor3d Inc. is recalling its Kinos Axiom Total Ankle System with Axiom PSR Flat-cut Cut Guide, REF 5831-9006. Incorrect patient-specific cutting guides can cause delayed surgery, poor alignment, implant loosening, or revision surgery in patients. Patients should contact their surgeon or restor3d to determine next steps.
The affected product is the Haylard Continuous Nerve Block Tray by AVID Medical, Inc., model BMCN001-05. The kits contain Sodium Chloride ampules with potential quality and sterility issues, exposing patients to risk of infection. Consumers should stop using the trays and contact AVID Medical for return or replacement instructions.
Medline Industries is recalling two Convenience Kits: Port Access Kit Univ of Ala (DYKM1414) and Arterial Line St Joes Syr Pack (DYNJ38145F). The kits contain sterile applicators that may be contaminated with Aspergillus penicillioides, which can cause serious infection, sepsis, or death in patients. Consumers should stop using the affected kits and contact Medline Industries for further instructions.
Howmedica Osteonics Corp. recalled Triathlon Hinge Insert size 4 11mm and 13mm orthopaedic implant components made from UHMWPE polyethylene. The plastic raw material was aged over five years, causing oxidation that can lead to wear, debris, fracture, or dissociation, exposing patients to revision surgery, pain, and inflammation. Patients who have these implants should contact their surgeon or healthcare provider to determine if any action is needed.
Medline Industries is recalling its convenience kits, including MINOR PACK DYNJ58421A and SPRINGHILL MINOR PACK DYNJ40734F. The sterile pouches may have open seals, which can compromise sterility and lead to contamination or patient infection. Consumers should check the pouch seals before use and not use any kit with an open seal.
The affected product is the Nova Biomedical StatStrip Glucose Hospital Meter System, model 66739. A software timing issue can cause a previous patient's barcode to remain displayed, so glucose results may be assigned to the wrong patient, exposing patients, especially critically ill, neonates, and infants, to incorrect treatment. Users should stop using the affected system and contact Nova Biomedical for recall instructions.
GE Healthcare's Enterprise Archive V8 software, all versions, is affected. Patients may have historical imaging data incorrectly linked to another patient's record, risking misdiagnosis or delayed care. Consumers should contact their healthcare provider to verify their records are correct.
The recall affects the Philips Patient Information Center iX, reference 866389. A software malfunction may cause the system to freeze and become unresponsive, affecting patients and healthcare providers. Users should contact Philips North America for instructions.
Stryker Sustainability Solutions is recalling the Ethicon Endo-Surgery XCEL Bladeless Trocar with Stability Sleeve, model REF:B11LT. The reusable access port may crack or separate during use, exposing patients and surgical staff to injury. Consumers should stop using the affected trocars and follow the recall instructions from Stryker Sustainability Solutions.
GE Healthcare's Workflow Core Services V8, all versions, is affected. Historical imaging data migrated from a legacy system may be linked to the wrong patient, risking misdiagnosis or delayed care for patients. Consumers should contact GE Healthcare for further instructions.
Howmedica Osteonics Corp. is recalling its Scorpio Recessed Metal Backed Patella orthopedic implant components, models 3045-0026, 3045-0028, 3045-0030, and 3045-0032. The polyethylene material may have aged beyond five years, causing oxidation, increased wear, debris, fracture, or disassociation, leading to revision surgery, pain, and inflammation for patients. Patients should contact their surgeon or hospital to check if they received an affected device and discuss next steps.
BD is recalling certain Alaris Pump Infusion Sets used with infusion pumps. Performance data discrepancies may lead to inappropriate pump performance, putting patients receiving infusion therapy at risk. Consumers should stop using affected sets and contact their healthcare provider or BD for replacement instructions.
The recall affects SunMed Tracheal Tube, Size 2.5, Model Number 1-7333-25 by Well Lead Medical Co. Ltd. The hazard is that a 6Fr suction catheter cannot pass through the tube smoothly, affecting patients who require suctioning. Consumers should stop using the affected tubes and contact the firm for return instructions.
Straumann USA LLC is recalling the GM Helix Implant, reference 109.984. The packaging may show different dimensions than the implant inside, posing a risk to patients who receive the wrong size. Patients should contact their healthcare provider to determine if their implant is affected and arrange for replacement.
embecta Medical II LLC distributed Nano Pro Un-Cannulated Demo Samples pen needles, catalog number 320550, labeled for investigational use only. These demo samples were inadvertently sold as commercial devices, exposing patients to needles not approved for regular use. Consumers should stop using them and contact embecta Medical II LLC for return and replacement instructions.
Howmedica Osteonics Corp. is recalling orthopaedic implant components made from aged polyethylene, including bearing and axle bushing assemblies and glenoid components. The aged plastic can oxidize and wear, causing debris, fracture, or disassociation, which may lead to revision surgery, pain, and inflammation for patients worldwide. Consumers who have these implants should contact their healthcare provider for guidance.
Nova Biomedical Corporation's StatStrip Glucose and B-Ketone meter, Model 66429, is affected. A software barcode retention issue can assign glucose results to the wrong patient's record, exposing critically ill patients, neonates, and infants to inappropriate care. Consumers must be aware that the firm initiated a voluntary recall.
GE Healthcare is recalling Core Services Hub V8, all versions, including XE and WFC services. The hazard is that migrated imaging data may be linked to the wrong patient, risking misdiagnosis or delayed care for patients. Users should contact GE Healthcare for instructions on the voluntary recall.
AVID Medical, Inc. is recalling Halyard IV START KIT NON-STERILE REF: KRIV26-02. The kit contains applicators contaminated with Aspergillus penicillioides, posing a risk to patients. The firm initiated a voluntary recall, so consumers should follow the company's instructions.
ICU Medical, Inc. is recalling IV Sets with drip chambers. The drip chambers may contain black specks or discolored PVC, which could enter the fluid path and harm patients receiving IV therapy. Consumers should stop using the affected sets and contact ICU Medical for instructions.
Howmedica Osteonics Corp. is recalling certain SCORPIO and SYSTEM ONE bipolar orthopedic implant components made of polyethylene. The aged plastic may oxidize and wear, causing debris, fracture, or separation, which can lead to pain, inflammation, or revision surgery for patients. Patients who have these implants should contact their surgeon or healthcare provider to determine next steps.
Bard Access Systems is recalling its Power-Trialysis and Power-Trialysis Slim-Cath short-term dialysis catheters. The class I recall means the catheters may cause serious injury or death to patients using them. Consumers should stop using the recalled catheters and contact Bard Access Systems for instructions.
Medline Industries is recalling certain Medline Convenience Kits with specific catalog numbers. The kits contain sterile applicators with possible Aspergillus penicillioides fungal contamination, which can cause serious infection, sepsis, or death in patients. Consumers should stop using the affected kits and contact Medline for instructions.
Howmedica Osteonics Corp. is recalling certain DURACON XL angled tibial inserts and shoulder glenoid components made from aged polyethylene. Patients implanted with these orthopedic devices face risks of increased wear, debris, fracture, or disassociation, which can cause pain, inflammation, and revision surgery. Consumers should contact their surgeon or healthcare provider to determine if their device is affected and discuss next steps.
Howmedica Osteonics Corp. is recalling certain knee and hip implant components made from aged polyethylene. The plastic may oxidize and wear, causing debris, fracture, or loosening, which can harm patients who received these implants. Patients should contact their surgeon or hospital to determine if they have an affected device and discuss next steps.
Stryker Sustainability Solutions is recalling the Ethicon Endo-Surgery XCEL Bladeless Trocar with Stability Sleeve, model REF:B12LT. The reusable access port system may crack or separate during use, posing a risk to patients and healthcare workers. Consumers should stop using the affected device and contact Stryker for return instructions.
Happiest Baby, Inc. SNOO Sleep Sack infant sleep sacks in Extra Small and Extra Large sizes are affected. These products have not been reviewed for safety and effectiveness by the FDA, exposing infants to potential unverified risks. Consumers must stop using the affected sleep sacks because they have not been reviewed by the FDA.
Medline Industries is recalling its ANESTHESIA PAIN PK LEAGUE DYNJ67925A convenience kits. The kits may have open seals in sterile packaging, risking contamination and patient infection. Consumers should inspect the packaging for open seals and not use affected kits.
The recall affects VERIQA RT MonteCarlo 3D v3 software, model S070031.520, version 3.1.18, from PTW FREIBURG. The software may not clearly show a bolus in treatment plans, causing radiation to be delivered to the wrong tissue depth for patients. Consumers should contact their treatment provider to ensure the software is updated or corrected.
The recall affects the NOxBOXi Nitric Oxide Delivery System by NOXBOX Ltd. Leaks in the oxygen tubing or connections can cause oxygen desaturation in patients using the device. Consumers should follow the firm's voluntary recall instructions.
ICU Medical, Inc. is recalling IV sets with drip chambers. The drip chambers may contain black specks or discolored material that could enter the fluid path, exposing patients to particulate matter. Consumers should consult the recall notice for instructions.
Medline Industries is recalling its Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A. The kits may have open seals in sterile pouch packaging, which can compromise sterility and lead to patient infection. Consumers should check the packaging for open seals and contact Medline Industries for further instructions.
AVID Medical, Inc. is recalling its Haylard BASIC BIOPSY TRAY, model PM415. The kits may have sterility and quality issues due to included Sodium Chloride ampules recalled by Spectra Medical, posing a risk to patients. Consumers should stop using the tray and follow the recall instructions for return or replacement.
Maquet Cardiopulmonary GmbH is recalling its Percutaneous Insertion Kit (PIK) with Guidewire 150 cm, model numbers 701053069 (USA) and 701047385 (OUS). The packaging may not consistently maintain sterile barrier integrity, exposing patients and healthcare providers to infection risk. Consumers should follow the firm's voluntary recall instructions for the affected kits.
Abiomed is recalling its Impella Optical Controller, Automated Impella Controller, and Impella Connect Package devices. The purge flag component in the purge pressure sensor assembly may fail, causing purge cassette recognition issues and exposing patients to risk. Consumers should contact Abiomed or their healthcare provider for instructions.
Boston Scientific Corporation is recalling the power adaptor for its StoneSmart Connect Console. The adaptor may have higher-than-expected grounding resistance, causing it to fail electrical safety testing, affecting users worldwide. The recall is voluntary and firm-initiated, so consumers should follow the recall notice.
Medline Industries is recalling certain Medline Convenience Kits, including blood and urine collection kits, with specific catalog numbers. The kits contain sterile applicators that may have fungal contamination, which can cause serious infection, sepsis, or death in patients. Consumers should stop using affected kits, check the catalog numbers, and follow the recall instructions for return or replacement.
Medline Industries is recalling certain Convenience Kits, including Open Heart Adult, Full Line Aneurysm CDS, and Non Sterile Chest Tube Removal. The kits contain sterile applicators that may be contaminated with Aspergillus penicillioides, posing a risk of serious infection, sepsis, or death to patients. Consumers should stop using the affected kits and contact Medline Industries for return instructions.
GE Healthcare's Centricity Enterprise Archive V2, V3, and V4 software, all versions, is affected. The hazard is that historical imaging data may be incorrectly associated with a different patient, exposing patients to misdiagnosis or delayed care. Consumers should contact their healthcare provider to verify their imaging records.
Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.