MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Mozarc Medical US
Class I - Dangerous
A potential issue with the seal integrity of header bag packaging.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Mozarc Medical US
Class I - Dangerous
A potential issue with the seal integrity of header bag packaging.
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Mozarc Medical US
Class I - Dangerous
A potential issue with the seal integrity of header bag packaging.
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
Mozarc Medical US
Class I - Dangerous
A potential issue with the seal integrity of header bag packaging.
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Mozarc Medical US
Class I - Dangerous
A potential issue with the seal integrity of header bag packaging.
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Mozarc Medical US
Class I - Dangerous
A potential issue with the seal integrity of header bag packaging.
Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Integra LifeSciences Corp. (NeuroSciences)
Class I - Dangerous
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
Potential for contamination with cotton fibers.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Surgical Theater
Class I - Dangerous
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Surgical Theater
Class I - Dangerous
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
Potential for contamination with cotton fibers.
Due to incomplete seals in the pouch which provide the sterile barrier.
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Medline Industries
Class I - Dangerous
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Class I - Dangerous
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.