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Verified recalls, refunds, lawsuits, and settlements involving Olympus Corporation of the Americas.
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. Product details: POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider,...
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. Product...
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers. Product details: Olympus Single Use...
Potential for detachment of a distal tip component of the device during use. Product details: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
XXX Product details: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.