Potentially have non-conforming internal threads.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class I - Dangerous
Defect consists of a small crack in the top end of the barrel near the needle.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class I - Dangerous
The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
Arrow International
Class I - Dangerous
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. This meter contains the incorrect unit of measure mg/dL instead of mmol/L.
ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Accuray Incorporated
Class I - Dangerous
the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and may introduce up to 0.5 mm of positional inaccuracy to the CyberKnife System
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).