FDA Medical devices recall ·
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000 recall
- Recall number
- Z-2741-2026
- Date
- (initiated June 2, 2026)
- Company / brand
- Maquet Cardiovascular, LLC
45 Barbour Pond Dr, Wayne, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 205 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI 00607567700406, Serial/Lot Number 3000547797
Distribution
US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
States: California Florida Georgia New York Oregon South Carolina Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2741-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.