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.

Class II

Recalling firm: Maquet Cardiovascular, LLC
Reason for recall: 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.
Affected products (lot / model / serial): UDI 00607567700406, Serial/Lot Number 3000547797
Units affected: 205 units
Distribution pattern: US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
Firm location: Wayne, NJ, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Telephone
Product type: Devices
Status: Ongoing
Recall number: Z-2741-2026
Recall initiated: June 2, 2026
FDA classification date: July 15, 2026
FDA report date: July 22, 2026
FDA event ID: 99259
Last updated on HTM Vibe: July 28, 2026