602 alerts recorded, refreshed every six hours. Filter by source or category.
ICU Medical, Inc. is recalling its IV Non-Dedicated Gravity Administration Sets with drip chambers. The drip chamber walls may contain black specks of discolored PVC that, if seen by a healthcare provider, could lead to product replacement and delayed patient therapy. Healthcare providers should replace affected sets before use to avoid delays in treatment.
Howmedica Osteonics Corp. is recalling its TRIDENT 0° POLY INSERT 28mm ID 620-00-28D orthopaedic implant components made from UHMWPE polyethylene. The affected devices may have elevated oxidation causing increased wear, debris, fracture, or disassociation, leading to revision surgery, pain, and inflammation for patients worldwide. Patients should contact their healthcare provider to confirm if their implant is affected and discuss next steps.
Howmedica Osteonics Corp. is recalling its OMNIFIT SERIES I ACET. INSERT 10° 22mm ID Catalog No. 2001-2246 orthopaedic implant components made from UHMWPE. The affected implants may have elevated oxidation from aged raw material, causing increased wear, debris, fracture, or dissociation, which can lead to revision surgery, pain, and inflammation for patients. Patients who have this implant should contact their healthcare provider or the company for further instructions.
Medline Industries is recalling two Convenience Kits, catalog numbers DYNDH1193 and DYNDH1487A. The kits contain sterile applicators that may have Aspergillus penicillioides fungal contamination, which can cause serious infection, sepsis, or death for users. Consumers should consult the FDA recall notice for affected lot numbers and follow the recall instructions.
The affected product is the Abiomed Impella Optical Controller, with product codes 0042-0010-AU, EU, IN, UK, and US. The hazard is potential purge cassette recognition issues due to failure of the purge flag component, exposing patients to device malfunction. Consumers should contact Abiomed or their healthcare provider for recall instructions.
Maquet Cardiopulmonary GmbH is recalling its Percutaneous Insertion Kit (PIK) with Guidewire 100 cm, model numbers 701053068 and 701047384. The packaging may not consistently maintain sterile barrier integrity, exposing patients and healthcare providers to infection risk. Consumers should stop using the affected kits and contact Maquet Cardiopulmonary for replacement or further instructions.
Wilson-Cook Medical Inc. is recalling its HEMOSPRAY Endoscopic Hemostat models HEMO-7, HEMO-10, HEMO-7-EU, and HEMO-10-EU. The device may fail to adhere to the endoscope and spray powder, exposing patients undergoing gastrointestinal endoscopy to risk of uncontrolled bleeding. Consumers should follow the updated Instruction for Use provided by the firm.
Bayer Medical Care's MEDRAD Stellant FLEX Syringe Kit (catalog FLEXS-150-QFT) used with the Stellant FLEX CT Injection System is affected. The hazard is that some kits may not have been properly sterilized, exposing patients to infection risk. Consumers should stop using the affected kits and contact Bayer Medical Care for instructions.
The recall affects Pi-Cardia Inc.'s ShortCut transfemoral catheter, model REF Z-A-20.003-US. The positioning arm may detach due to a weld issue, posing a risk to patients undergoing the procedure. Consumers should follow the voluntary recall instructions from Pi-Cardia Inc. to return or replace the device.
GE Healthcare's Centricity PACS V2, V3, V4, V6, and V7 software is recalled. Under certain conditions, migrated imaging data may appear under the wrong patient record, risking misdiagnosis or delayed care for patients. Users should contact GE Healthcare to obtain instructions for addressing the recall.
Stryker Sustainability Solutions is recalling the Ethicon Endo-Surgery XCEL Bladeless Trocar with Stability Sleeve, model B5LT. The reusable access port system may crack or separate during use, exposing patients and healthcare providers to injury. Consumers should stop using the affected devices and contact Stryker Sustainability Solutions for return and replacement instructions.
Howmedica Osteonics Corp. recalled certain acetabular cups and constrained inserts made from ultra-high molecular weight polyethylene. The plastic may have elevated oxidation causing wear, fragments, fracture, or separation, leading to revision surgery, pain, and inflammation for implanted patients. Patients should contact their healthcare provider to check if their device is affected and discuss what to do.
Howmedica Osteonics Corp. is recalling certain orthopedic implant components made from UHMWPE polyethylene, including acetabular inserts, tibial inserts, and other parts. The plastic may have elevated oxidation from aged raw material, causing wear, debris, fracture, or disassociation, leading to pain, inflammation, or revision surgery for implanted patients. Patients should contact their surgeon or healthcare provider to identify if their implant is affected and discuss next steps.
Mirion Technologies (Capintec) is recalling its Captus 4000e Thyroid Uptake System, models 5430-30151, 5430-30152, and 5430-30154. The tension bolt can fail, causing the spring arm to unexpectedly drop about 25 inches, posing an injury risk to users and patients. Consumers should stop using the affected device and contact Mirion Technologies for repair or replacement.
Stryker Sustainability Solutions is recalling the Ethicon Endo-Surgery XCEL Bladeless Trocar with Stability Sleeve, model REF:B5ST. The reusable access port system may crack or separate during use, exposing patients and surgical staff to injury. Consumers should stop using the affected device and contact Stryker Sustainability Solutions for return and replacement instructions.
The Reign Medical Clench Staple System (Compression) bone fixation staple is recalled in multiple sizes. The device's performance characteristics have not been adequately established, posing a risk to patients. Consumers should stop using the recalled staples and follow the firm's instructions.
Howmedica Osteonics Corp. recalled SCORPIO C-DOME and U-DOME PATELLA orthopaedic implant components made from UHMWPE. The aged polyethylene may oxidize and wear excessively, causing debris, fracture, or dissociation, leading to revision surgery, pain, and inflammation in patients worldwide. Patients should contact their orthopaedic surgeon to discuss the recall and next steps.
Medline Industries is recalling its Medline Convenience Kit, the Anesthesia L&D A-Line Set, catalog number DYKMBNDL199A. The kits contain sterile applicators that may have fungal contamination, which can cause serious infection, sepsis, or death in patients. Consumers should stop using the affected kits and contact Medline Industries for instructions.
Philips North America is recalling its PIC iX Essentials patient information system, model REF:867093. A software malfunction can freeze the system, affecting patients and healthcare providers who rely on it. Consumers should contact Philips North America for instructions.
ICU Medical, Inc. is recalling its IV Sets with drip chambers. The drip chambers may contain black specks or discolored material that could enter the fluid path, posing a risk to patients receiving intravenous therapy. Consumers should contact ICU Medical for instructions.
ICU Medical Plum administration sets are affected. The drip chambers may contain black specks, and particulate matter in the fluid path has not been ruled out, exposing patients to potential harm. Consumers should stop using the affected sets and contact ICU Medical for instructions.
The recall affects Nova Biomedical's StatStrip Glucose Hospital Meter System, model 63685. A software timing issue can keep a previous patient's barcode on screen, so glucose results may be assigned to the wrong patient, endangering critically ill patients, neonates, and infants. Users should follow the recall notice from Nova Biomedical for return and correction instructions.
Nova Biomedical is recalling its StatStrip Glucose and B-Ketone meter, model 63683, a glucose test system. A software timing issue can keep a previous patient's barcode on screen, so a current patient's glucose result may be saved to the wrong medical record, affecting critically ill patients, neonates, and infants. Nova Biomedical initiated a voluntary recall; users should contact the company for instructions.
AVID Medical, Inc. is recalling Haylard UNIV IMAGING BIOPSY TRUCUSTOM kits, model VARV042-03. The kits may have product quality and sterility issues because they contain Sodium Chloride ampules recalled by Spectra Medical, posing a risk to patients. Consumers should stop using the affected kits and contact AVID Medical for further instructions.
Abiomed is recalling its Automated Impella Controller (AIC) devices with specific product codes. The purge flag component in the purge pressure sensor assembly can fail, leading to purge cassette recognition issues that put patients at risk. Consumers should contact Abiomed or their healthcare provider to arrange for corrective action.
GE Healthcare's Centricity PACS Server V7, all versions, is affected. The hazard is that migrated images may be linked to the wrong patient, risking misdiagnosis or delayed care for patients. Users should contact GE Healthcare to arrange for corrective action.
The affected product is the Happiest Baby, Inc SNOO Sleep Sack, X-Small, with model numbers S2101-101, S2101-108-6, S2101-133, S2102-112, S2107-101, and S2107-110. The hazard is that these extra small and extra large infant sleep sacks have not been reviewed for safety and effectiveness by the FDA, exposing infants to potential unverified risks. Consumers should stop using the recalled sleep sacks and contact Happiest Baby, Inc for further instructions.
ICU Medical 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 stop using affected sets and contact ICU Medical for instructions.
Medline Industries is recalling its Medline Convenience Kit: OPEN HEART A PACK, product number DYNJ43008N. The kit contains a cannula with a possible sterile barrier breach, exposing patients to risk of infection or other complications. Consumers should check the pouch seal before use and contact Medline if it is compromised.
ICU Medical oncology sets with drip chambers are affected. The drip chamber walls may contain black specks, which could lead healthcare providers to replace the product and delay patient therapy. Consumers should follow the recall instructions from ICU Medical.
The recall affects the Aisys CS2 Datex-Ohmeda anesthesia system, part number 1011-9055-000. The device can switch to Alternate O2 control, interrupting anesthetic delivery and risking reduced anesthetic effect for patients unless a clinician intervenes. Users should stop using affected units and contact Datex-Ohmeda for corrective instructions.
ICU Medical oncology sets with drip chambers are affected. The drip chamber walls may have black specks from molding, which healthcare providers might see and replace the product, delaying therapy for patients. Consumers should have the product replaced before use if black specks are seen.
The affected product is the Nova Biomedical StatStrip Glucose and B-Ketone meter, model 63910, glucose test system. A software timing issue can retain a previous patient or QC barcode, causing glucose results to be assigned to the wrong patient record, exposing critically ill patients, neonates, and infants to inappropriate treatment. Users must confirm the displayed patient ID matches the current patient before accepting any test result.
GE Medical Systems Information Technologies Inc is recalling its Carescape Central Station CSCS V3 MAS800 Desktop and MAI800 Integrated devices. The devices may fail to resume patient monitoring for at least 3 minutes after a system restart, potentially delaying recognition of clinically significant events for patients. Consumers should contact GE Medical Systems Information Technologies Inc for instructions on how to address this issue.
Medline Industries is recalling its Convenience Kits with catalog numbers DYKM1000B and DYKM2187A. The kits contain sterile applicators that may have fungal contamination, exposing patients to risk of serious infection, sepsis, and death. Consumers should review the FDA recall notice and follow the firm's instructions.
AVID Medical is recalling its Haylard 18G Single Shot Epi Tray, model DPGE002-02. The kits contain Sodium Chloride ampules with potential quality and sterility issues, posing a risk to patients. Consumers should stop using the affected trays and contact AVID Medical or their healthcare provider for instructions.
Datex-Ohmeda, Inc. is recalling its Et Control software option for anesthesia gas machines, including field replaceable units 1011-8000-000-S and 5700665. The affected systems can switch to Alternate O2 control, interrupting anesthetic agent delivery and requiring clinician intervention; without it, patients may experience decreased anesthetic effect. Clinicians must intervene if the system switches to Alternate O2 control, to prevent the patient from experiencing decreased anesthetic agent effect.
The recall affects Datex-Ohmeda Aisys CS2 with Et Control anesthesia systems, part number 1011-9000-000. The system may switch to Alternate O2 control, interrupting anesthetic agent delivery, exposing patients to decreased anesthetic effect without clinician intervention. Clinicians must intervene to maintain anesthesia and respond to alarms.
Stryker Sustainability Solutions is recalling the Ethicon Endo-Surgery XCEL Bladeless Trocar with OptiView Technology and Sleeve, 5mm x 75mm, reference 2B5ST. The reusable access port system may crack or separate during use, exposing patients and surgical staff to injury. Consumers should stop using the affected device and contact Stryker Sustainability Solutions for return and replacement instructions.
Getinge PVC Thoracic Catheters, Soft PVC Right Angle, in sizes 24FR, 28FR, 32FR, and 36FR, are recalled. The catheters may contain elevated bacterial endotoxins, posing a risk of fever or severe reaction to patients. Consumers should stop using the recalled catheters and contact Getinge/Atrium Medical for return and replacement instructions.
C.R. Bard Inc. is recalling certain Bardex and SureStep Foley Catheter Trays that contain Pericare Wipes. The wipes may be contaminated on their surface, posing a risk to patients using these urological catheter trays. Consumers should stop using affected products and contact C.R. Bard or the FDA for instructions.
The recall affects Given Imaging Ltd. Bravo CF capsule delivery devices, product numbers FGS-0635 and FGS-0636, used to attach a pH monitoring capsule to the esophagus. The capsule may fail to attach or detach, exposing patients to aspiration, esophageal perforation, airway obstruction, bleeding, laceration, delayed diagnosis, or retained foreign bodies. Consumers should stop using the affected devices and contact their healthcare provider.
Nipro Renal Solutions USA Corporation is recalling Citric Complete Dry Citric Acid Concentrate, references DCA+200-25 and DCA+203-25. The concentrate has high endotoxin levels, which can cause fever or severe reactions in hemodialysis patients. Consumers should stop using the recalled product and contact their dialysis provider or Nipro for instructions.
C.R. Bard Inc. is recalling Pericare Wipes included in SureStep Intermittent Catheter Trays and Preamendment trays. The wipes may have surface contamination, exposing patients using these urological catheter trays to potential infection. Consumers should stop using the affected trays and contact C.R. Bard for instructions.
The recall affects Medical Action Industries' Epidural/Pain TQC kit, REF 82465, containing Sodium Chloride Injection 0.9% USP 10ml ampules. The hazard is potentially compromised sterility, exposing patients who receive these kits to infection risk. Consumers should stop using the recalled kits and contact the firm for return or replacement.
AVID Medical, Inc. is recalling the Halyard IV Start Kit Non-Sterile REF: KRIV26-02. The kits contain applicators that lack sterility assurance due to wrinkles in the paper lidding, exposing patients to infection risk. Consumers should stop using the affected kits and follow the recall instructions.
Medical Action Industries is recalling its Single Shot Epidural kits, references 59553 and 83945B, which contain 0.9% sodium chloride injection ampules. The kits may have compromised sterility, posing a risk to patients receiving epidural procedures. Consumers should stop using the recalled kits and contact Medical Action Industries for instructions.
Windstone Medical Packaging, Inc. is recalling its AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B. The kits may contain blue Break-off-Parts that detached from the infusion port, posing a hazard to patients. The firm initiated a voluntary recall of the affected kits.
Nipro Renal Solutions USA Corporation is recalling MedicaLyte Bicarbonate Powder in specific REFs. The powder contains high endotoxin levels, posing a risk to hemodialysis patients. Consumers should stop using the recalled powder and follow the firm's recall instructions.
C.R. Bard Inc. is recalling SureStep Foley Tray Systems and Bardex IC Complete Care products that contain Pericare Wipes. The wipes may have surface contamination, exposing patients using these urological catheter trays to potential infection. Consumers should stop using the affected products and follow the firm's recall instructions.
Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.