95,102 total recalls in our database
Karl Storz Endoscopy
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Karl Storz Endoscopy
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Instrumentation Laboratory
Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
Woodside Acquisitions
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
American Contract Systems
Product was sterilized with a higher than specification EO concentration.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Olympus Corporation of the Americas
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
American Contract Systems
Product was sterilized with a higher than specification EO concentration.
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Olympus Corporation of the Americas
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
SIMPLIVIA HEALTHCARE
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure applied will be higher than 150 mmHg and the deflation pressure will be higher than 5 mmHg. An applied cuff inflation pressure higher than 150mmHg or a deflation pressure higher than 5 could lead to bruising, mmHg nerve damage or bone deformity for a neonate.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
Karl Storz Endoscopy
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
Microtek Medical
Latex content in product was labeled incorrectly as latex free.
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
USA Medical
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.