Olympus America Inc.

Complete recall history across all FDA and CPSC categories — 5 total recalls

Olympus America Inc. appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (4)

FDA medical device enforcement actions by Olympus America Inc.

Date Product Reason Class
Mar 26, 2015 EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument ha... New and validated reprocessing procedures have been issued for the Olympus TJ... Class II
Sep 27, 2013 TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm,... Complaints of damage to various models of Thunderbeat Hand Instruments during... Class II
May 20, 2013 Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tiss... There is a possibility that the pump head was not shipped in the locked posit... Class II
Nov 10, 2009 Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: ... Olympus initiated a software upgrade and enhancement in 2009 and completed th... Class II

Product Recalls (1)

CPSC consumer product recalls by Olympus America Inc.

Date Product Hazard
Mar 13, 2006 Various Olympus-Brand 35mm Film Cameras A defect with the flash circuit in these cameras can cause it to smoke and overheat when the came...

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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