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All product recalls associated with Gyrus Medical, Inc.
Total Recalls
3
Past Year
0
Class I (Serious)
0
Most Recent
Aug 2014
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.
Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of serious injury to patient, testing indicated that the possibility exists.
The generator may malfunction when used in close proximity to a monopolar generator.