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Gyrus Acmi, Incorporated

Complete recall history across all FDA and CPSC categories — 6 total recalls

Gyrus Acmi, Incorporated 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 (6)

FDA medical device enforcement actions by Gyrus Acmi, Incorporated

Date Product Reason Class
Apr 17, 2018 Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C6... There is a potential for the cord to spark and cause a fire. Class II
May 8, 2015 Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, ... Potential lack of sterility assurance. Class II
May 8, 2015 Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, ... Potential lack of sterility assurance. Class II
Oct 21, 2014 Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and RE... All packages of Falope Ring Band Applicator kits are being recalled due to co... Class II
May 24, 2013 GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 13071... lack of sterility assurance Class II
Oct 17, 2012 PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, ST... One lot of tympanostomy tubes were manufactured with silicon that was found t... 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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