Gyrus Medical, Inc
Complete recall history across all FDA and CPSC categories, 4 total recalls
Gyrus Medical, 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 (4)
FDA medical device enforcement actions by Gyrus Medical, Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 27, 2014 | GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS... | Due to an anomaly in the packaging process, it is possible that a defective s... | Class II |
| Jul 8, 2014 | Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a ... | Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold ... | Class II |
| Feb 19, 2014 | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and R... | Due to an anomaly in the packaging process for specific lots of Disposable Fa... | Class II |
| Jul 24, 2013 | GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, St... | On April 29, 2013 Olympus Surgical Technologies America R&D received results... | 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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