Gyrus ACMI Corporation Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery within an ambient air environment. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery within an ambient air environment.
Brand
Gyrus ACMI Corporation
Lot Codes / Batch Numbers
Lot Numbers: 0805064, 0805102, 0805103, 0806030, 0806039, 0806187, and 0807021
Products Sold
Lot Numbers: 0805064, 0805102, 0805103, 0806030, 0806039, 0806187, and 0807021
Gyrus ACMI Corporation is recalling Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electr due to Sterility may be compromised. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility may be compromised
Recommended Action
Per FDA guidance
Gyrus ACMI initiated a voluntary recall by an Urgent: Medical Device Recall letter on 10/01/08 informing accounts of the problem, cease any further use of the affected product, remove any of the affected product service representative to obtain a Return Goods Authorization, return the product, and complete the reply form and fax it to the Regulatory Affairs Dept. so that the response can be tracked.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026