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323 reported ongoing
327 records in this archive. Latest source date Aug 18, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
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 risk of infection or sepsis.
Class IIReported ongoing
Distribution: Domestic US distribution nationwide.
Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect the instructions in ...
Class IIReported ongoing
Distribution: International distribution to the country of Japan.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Class IIReported ongoing
Distribution: US Nationwide distribution.
The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
Class IIReported ongoing
Distribution: International distribution only.
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Mexico, P.R. China, Singapore, South Korea.
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
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia.
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 to retained distal cover in the gastrointestinal tract that would r...
Class IIReported ongoing
Distribution: US Nationwide distribution.
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 fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
Class IIReported ongoing
Distribution: US Nationwide. Global Distribution
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 fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
Class IIReported ongoing
Distribution: US Nationwide. Global Distribution
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 not noticed prior to use in patient).
Class IIReported ongoing
Distribution: Domestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS KY LA MA MI NC ND NE NJ NY OR PA SC SD TN TX VA WI International distribution to Canada, Latin Ameri...
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 potential for the fiber to break during use, which may cause burns...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Europe, Hong Kong, Australia, Japan, Singapore, and Latin America.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 327 records, including 323 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.