Overview of recall records associated with Olympus Corporation of the Americas, including dates, categories and classifications where available.
Classification mix: Class II: 217, Class I: 14, Class III: 2.
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due…
The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot
Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a…
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents…
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile…
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if…
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile…
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of…
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of…
Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts…
Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
This page summarizes recall records in which the official source identifies Olympus Corporation of the Americas as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
