EPA (Environmental Protection Agency)
1 records
fda
11 records
FDA Recall: Gyrus ACMI, Inc. — Class II
20190424
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | Product: Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standar...
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FDA Device Recall: Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part
2019-04-24
Class II — Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
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FDA Device Recall: Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040
2019-04-24
Class II — Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
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FDA Device Recall: Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
2019-04-24
Class II — Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
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FDA Device Recall: Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
2019-04-24
Class II — Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
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FDA Device Recall: Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000S
2019-04-24
Class II — Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
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FDA Device Recall: Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-
2018-06-06
Class II — There is a potential for the cord to spark and cause a fire.
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FDA Device Recall: Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, deb
2015-06-17
Class II — Potential lack of sterility assurance.
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FDA Device Recall: Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, deb
2015-06-17
Class II — Potential lack of sterility assurance.
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FDA Device Recall: Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 0
2014-12-03
Class II — All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient ...
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FDA Device Recall: GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715,
2013-06-12
Class II — lack of sterility assurance
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