The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.

Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.

Getinge issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/18/2026 via FedEx. The notice explained the issue, risk to health, and requested the following actions be taken: " Immediately identify and quarantine all affected Vasoview Hemopro 2 devices from lot 3000547797. " Do not use affected devices. " If an affected device was used, no further intervention is required. Standard post-operative wound care per facility protocol should be followed. " If any affected devices were transferred within your organization or to another organization, ensure this notice is shared with the appropriate individuals. " Contact Getinge Customer Service 1-888-880-2874 or your Getinge representative to coordinate return of the affected units and replacement product. " Complete and return the enclosed response form to Getinge by e-mailing a copy to [email protected].