Recalling firm
Maquet Cardiovascular, LLC
Product type
Device
Status
Ongoing
Report date
2026-07-22
Distribution
US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
Firm state
NJ
Product quantity
205 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason 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.
Code / lot info
UDI 00607567700406, Serial/Lot Number 3000547797
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.