FDAHealthJune 2, 2026
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
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 2, 2026
US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
What's affected?
- Product
- 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.
- Lot code
- 3000547797
Additional details
UDI 00607567700406, Serial/Lot Number 3000547797
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 205 units.
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