🏥 Medical Devices • 15,203 recalls
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.
Microtek Medical
Latex content in product was labeled incorrectly as latex free.
Karl Storz Endoscopy
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.
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.
Kits were packed into shipping boxes incorrectly.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Daavlin Distributing Company
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.
American Contract Systems
Product was sterilized with a higher than specification EO concentration.
Johnson & Johnson Surgical Vision
Potential breach in the sterility barrier for tray ring covers.
Arthrex
Products do not meet length and diameter specifications.
Acera Surgical
Misprinted expiration date on the shelf-box
Becton Dickinson &
When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.
DePuy Orthopaedics
System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment