Z-2741-2026 Class II Ongoing
FDA device recall Z-2741-2026 was initiated by Maquet Cardiovascular, LLC on June 2, 2026 and is designated Class II. 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 STE… The recall status is ongoing. Affected quantity: 205 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2026
- Initiation Date
- June 2, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 205 units
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.
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 Pattern
US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
Code Information
UDI 00607567700406, Serial/Lot Number 3000547797