Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.
All Recalls
92,900 total recalls in our database
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
Baxter Healthcare
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.
The tube may fall into the surgical site during the grasping process.
Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
B. Braun Medical
Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.
General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
Cypress Medical Products
The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Boston Scientific
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers. " Internet Explorer 10 (IE10) " Internet Explorer 11 (IE11) " Firefox.
ViewPoint; system, imaging processing, radiological
GE Healthcare GmbH
The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.
Cabinet Heaters
Caframo Limited, of Canada
The crimp holding a wire in place in the cabinet heater is not properly finished and can result in the wire detaching, posing an electrocution hazard.
Ceither Adult Portable Bed Rails
Unknown Manufacturer
The recalled bed rails violate federal regulations for adult portable bed rails, posing a serious entrapment hazard and risk of death by asphyxiation. When the bed rails are attached to a bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress.
Newmemo Children's Ring Sets
Unknown Manufacturer
The rings contain levels of lead that exceed the federal lead content ban and levels of cadmium that are prohibited in children's products by the Federal Hazardous Substances Act. Lead and cadmium are toxic if ingested by young children and can cause adverse health effects.
Platform Beds with Upholstered Square Tufted Headboards
Unknown Manufacturer
The recalled beds can sag, break, or collapse during use, posing fall and injury hazards to consumers.
Place & Time battery-operated desk lamps
Unknown Manufacturer
The desk lamp's battery compartment can overheat while using the USB charging cord, posing a fire hazard.
Model Year 2024 RANGER XD 1500 and Crew XD 1500 Recreational Off-Road Vehicles (ROVs)
Polaris Industries Inc., of Medina, Minnesota
The winch wiring can overheat while in use, posing a fire hazard and risk of serious injury to the rider or passenger.
Model Year 2023-2024 Polaris Sportsman 850, XP 1000, and XP 1000 S ATVs and fuel pump kits and fuel tank assemblies
Polaris Industries Inc., of Medina, Minnesota
The ATV can leak fuel at the fuel pump flange outlet, posing a fire hazard and risk of serious injury to the rider or passenger.