The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000
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.
- Agency
- FDA Device
- Recall date
- Jun 2, 2026
- Status
- Ongoing
- Company
- Maquet Cardiovascular, LLC
1. What product was recalled?
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000
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.
Quantity: 205 units
Code or lot text: UDI 00607567700406, Serial/Lot Number 3000547797
- LOT
- Serial/Lot Number 3000547797
- LOT
- UDI 00607567700406
- RECALL-NUMBER
- Z-2741-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is 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.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
View source evidence for state distribution
- California: US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
- Florida: US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
- Georgia: US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
- New York: US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
- Oregon: US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
- South Carolina: US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
- Texas: US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.