FDAFDA · Food and drugs·Recall number Z-2741-2026
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.
Published July 22, 2026 · Recall initiated: June 2, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Maquet Cardiovascular, LLC
- Distributor
- US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
- Lot
- UDI 00607567700406, Serial/Lot Number 3000547797
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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