CLASS II ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System recalled
Maquet Cardiovascular is recalling The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (, distributed nationwide in the US. The recall was initiated on 2 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2741-2026
- FDA event ID
- 99259
- Recalling firm
- Maquet Cardiovascular, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Jun 2026
- FDA classified
- 15 Jul 2026
- Reported
- 22 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 2 Jun 2026 | Recall initiated by company | |
| 15 Jul 2026 | Classified by FDA | +43 days |
| 22 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
Nationwide CaliforniaFloridaGeorgiaNew YorkOregonSouth CarolinaTexas
Questions about this recall
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.
Which lots are affected?
UDI 00607567700406, Serial/Lot Number 3000547797
Where was it sold?
US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Maquet Cardiovascular
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|---|---|---|---|---|---|
| Device | CLASS II | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System recalled | Maquet Cardiovascular | Device Malfunction | Nationwide |
| Device | CLASS II | Heartstring III Proximal Seal System Intravascular recalled | Maquet Cardiovascular | Packaging Defects | Nationwide |
| Device | CLASS II | Heartstring III Proximal Seal System Intravascular recalled | Maquet Cardiovascular | Packaging Defects | Nationwide |
| Device | CLASS II | Heartstring III Proximal Seal System recalled by Maquet Cardiovascular | Maquet Cardiovascular | Packaging Defects | Nationwide |
| Device | CLASS II | The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System recalled | Maquet Cardiovascular | Device Malfunction | Nationwide |
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