Gyrus Medical Recalls
4 recalls on record · August 28, 2013 to October 29, 2014 · Medical Devices
Recalls by year
13
14
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 29, 2014Medical DevicesFDA
Gyrus Medical, Inc recalls GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest
Hazard: 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.
August 27, 2014Medical DevicesFDA
Gyrus Medical, Inc recalls Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component
Hazard: Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring band on the reusable Falope applicator.
March 19, 2014Medical DevicesFDA
Gyrus Medical, Inc recalls Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan)
Hazard: Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, 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. The breach may or may not be easily seen.
August 28, 2013Medical DevicesFDA
Gyrus Medical, Inc recalls GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF
Hazard: On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.