All recalls8,500 total
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Foreign object: black particulate matter
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information
Undeclared Sesame allergen
Contains statement does not declare Salmon
Contains statement does not declare Walnut
Contains statement does not declare Salmon
Contains statement does not declare Pistachio.
Contains statement does not declare Almond
Contains statement does not declare Walnut
Contains statement does not declare Walnut
Contains statement does not declare Salmon
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
Contains statement does not declare Salmon
Contains statement does not declare pecan.
Contains statement does not declare Salmon
Contains statement does not declare Almond
Contains statement does not declare Salmon
Contains statement does not declare Pollock
Contains statement does not declare Pollock
Contains statement does not declare Almond
Contains statement does not declare Salmon
Contains statement does not declare Almond
Contains statement does not declare pecan.
Contains statement does not declare Shrimp
Contains statement does not declare Salmon
Contains statement does not declare Cashew
Contains statement does not declare Almond
Contains statement does not declare Tilapia
Contains statement does not declare Almond
Contains statement does not declare TUNA
Contains statement does not declare Salmon
Contains statement does not declare Walnut
Contains statement does not declare Shrimp
Contains statement does not declare Shrimp.
Contains statement does not declare Shrimp.