Medical equipment, implants, and diagnostic devices
INARI MEDICAL
The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device must be used or suboptimal thrombus removal if the problem is not detected.
The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.
A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.
A manufacturing error resulted in out of specification R3 Acetabular Shells
Siemens Healthcare Diagnostics
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
Becton, Dickinson and Company, BD Biosciences
The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.
False positive results due to potential contamination of reagent.
Distributed to the field without having completed design history files or design transfer activities
Distributed to the field without having completed design history files or design transfer activities
A manufacturing error resulted in out of specification R3 Acetabular Shells
RAYSEARCH LABORATORIES AB
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
RAYSEARCH LABORATORIES AB
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
RAYSEARCH LABORATORIES AB
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
There is potential for the plastic optical tip to become detached from the metal shaft.
Distributed to the field without having completed design history files or design transfer activities
Distributed to the field without having completed design history files or design transfer activities
Olympus Corporation of the Americas
Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.
Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
Distributed to the field without having completed design history files or design transfer activities