Medical Device Recall: 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 K1012
Maquet Cardiovascular, LLC · June 2, 2026
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.
Product Description
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.
Distribution
US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
States Affected
NATIONWIDE
Quantity Affected
205 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2741-2026
Status: ongoing
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