Gyrus ACMI, Inc.

Complete recall history across all FDA and CPSC categories — 11 total recalls

Gyrus ACMI, Inc. appears in recall records across 1 category. 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 (11)

FDA medical device enforcement actions by Gyrus ACMI, Inc.

Date Product Reason Class
Mar 8, 2019 Olympus Diego Elite Console MDCONS 100 Olympus Diego Elite Consoles may inadvertently permit activation of the RF en... Class II
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC Olympus Diego Elite Consoles may inadvertently permit activation of the RF en... Class II
Mar 8, 2019 Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS Olympus Diego Elite Consoles may inadvertently permit activation of the RF en... Class II
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB... Olympus Diego Elite Consoles may inadvertently permit activation of the RF en... Class II
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4... Olympus Diego Elite Consoles may inadvertently permit activation of the RF en... Class II
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB40... Olympus Diego Elite Consoles may inadvertently permit activation of the RF en... Class II
Mar 8, 2019 Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS Olympus Diego Elite Consoles may inadvertently permit activation of the RF en... Class II
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS Olympus Diego Elite Consoles may inadvertently permit activation of the RF en... Class II
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4... Olympus Diego Elite Consoles may inadvertently permit activation of the RF en... Class II
Mar 8, 2019 Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A P... Olympus Diego Elite Consoles may inadvertently permit activation of the RF en... Class II
Aug 3, 2017 Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system "Chattering" when cutting burrs are used in bone. Class II

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.

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