🏥 Medical Devices • 15,203 recalls
Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance.
CooperSurgical
Products in this lot may have compromised barrier seals, introducing a risk to sterility.
It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.
ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into Total Resources Intl kits. Acetaminophen and electrolyte tablets were recalled due to a Fluid Bed Drier exhaust system breach, which presents the possibility of cross-contamination where the potential contaminations are well known API's at well below efficacious dose levels.
Olympus Corporation of the Americas
The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
Karl Storz Endoscopy
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
bioMerieux
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
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
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
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.
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.