Maquet Cardiovascular, LLC: 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 FD

Hazard

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.

Details from the source

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. Distribution: US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR. Quantity: 205 units Lot/code info: UDI 00607567700406, Serial/Lot Number 3000547797

UPC codes

00607567700406

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.