Manufacturer
332 recalls in our database name Olympus Corporation of the Americas as the manufacturing or recalling firm.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Olympus Corporation of the Americas is recalling Colonoscope Model PCF-Q180AL units that were assembled without protective adhesive. This missing adhesive protects the device from vibration, temperature fluctuations, and physical shock during use.
Olympus Corporation is recalling 18 colonoscopes with missing adhesive that protects against physical stress. The missing protective adhesive could allow device failure under vibration, temperature fluctuation, or shock.
Olympus is recalling two colonoscopes (Model CF-Q180AL, serial numbers 2602060 and 2603763) due to missing protective adhesive that normally guards against vibration, temperature changes, and shock loads.
Olympus is recalling 36 colonoscopes with specific serial numbers that lack a protective adhesive, risking device failure if exposed to vibration, temperature changes, or shock loads.
Olympus Corporation of the Americas is recalling ESG PK Cutting Forceps because the jaw may fracture during pre-procedure inspection or during the procedure, posing a potential injury risk.
Olympus Single Use Distal Cover MAJ-2315 may detach from duodenovideoscopes during gastrointestinal procedures, risking perforation, retained objects requiring urgent removal, burns, and airway obstruction.
Olympus MAJ-2318 water filters may be assembled incorrectly, allowing unfiltered tap water to contaminate reprocessed endoscopes and expose patients to infection risk.
Olympus Corporation of the Americas is recalling one lot of Paparella-Type Vent Tubes due to missing expiration date on the inner package, though the date is present on the outer packaging.
Olympus is recalling approximately 6,898 EZDilate Wire Guided Balloon devices due to reported bursting, leaking, and retrieval problems during medical procedures.
Olympus recalled 3,354 EZDilate wire-guided dilation balloons due to failures in inflation, deflation, and retrieval, with incidents of bursting, leaking, and foreign bodies left in patients.
Olympus is recalling EZDilate Fixed Wire Balloons for inflation and deflation failures. The devices may burst, leak, or leave foreign material in patients.
Olympus is recalling 2,991 EZDilate endoscopic balloons for problems with inflation and deflation. Reports include device bursting and leaking, and retained foreign bodies in patients during procedures.
Olympus recalled 3,767 EZDilate Wire Guided Balloons due to reported inflation, deflation, and retrieval problems causing bursting, leaking, and foreign body lodgement in patients. The devices dilate strictures in the alimentary tract.
Olympus recalls EZDilate Wire Guided Balloon devices used for endoscopic dilation due to reported bursting, leaking, and retrieval failures affecting 1,639 units nationwide.
Olympus is recalling EZDilate Fixed Wire Balloon devices used for esophageal stricture treatment due to reports of inflation/deflation failures, bursting, leaking, and foreign body retention in patients.
Olympus recalled EZDilate Wire Guided Balloon endoscopic dilators due to reports of bursting, leaking, and retained foreign bodies during patient procedures. The Class II recall affects 4,182 units used to treat esophageal strictures.
Olympus recalls 1,008 EZDilate Fixed Wire Balloon devices nationwide due to malfunction during use. Reported failures include inflation and deflation problems, bursting, leaking, and foreign body events in patients.
Olympus is recalling 8,294 EZDilate Fixed Wire Balloon devices due to reports of device failures including bursting, leaking, and foreign body retention in patients undergoing esophageal dilation.
Olympus recalls approximately 5,031 EZDilate Fixed Wire Balloons due to device bursting, leaking, and foreign body incidents during esophageal dilation procedures. Patients should contact their healthcare provider if they received this device.
Olympus is recalling EZDilate Fixed Wire Balloons used for esophageal dilation due to reports of bursting, leaking, and difficulty retrieving the device. The recall affects 1,796 units distributed nationwide and internationally.
Olympus Corporation recalled 236 fiber cleaver units distributed non-sterile but labeled as reusable and autoclavable. Without validated sterilization instructions, use on sterile fiber poses contamination risk.
Olympus Corporation recalls 179 SOLTIVE SuperPulsed Laser Fibers due to potentially breached sterile pouch seals that could cause procedure delays or patient infections if not detected before use.
Olympus is recalling 82,200 units of SOLTIVE SuperPulsed Laser Fibers due to instruction inconsistencies that could cause fiber breakage during use, potentially resulting in burns or foreign material in the patient.
Olympus recalls fiber stripper models sold before 2023 lacking validated sterilization instructions, creating a contamination risk when used on sterile medical fibers.
Olympus Corporation recalls 1,403 ENDOEYE Flex endoscopic videoscopes due to deviations in reprocessing instructions. Affected devices may not be reprocessed properly for safe reuse in surgical procedures.