FDAFDA recall Z-2741-2026 · Jul 22, 2026
Maquet Cardiovascular, LLC: The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000 recall
Recall found
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.
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI 00607567700406, Serial/Lot Number 3000547797
- Quantity
- 205 units
- Distribution
- US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
- Recalling firm
- Maquet Cardiovascular, LLC, Wayne, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-02
Source: openFDA enforcement record Z-2741-2026 · search recall number Z-2741-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.