Reported Oct 14, 2026 · Ongoing · Updated Oct 20, 2026
HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video…
Steris Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834
Is this the product you have?
- HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control
- Software Version2.0.18
- Lot codes and dates
- Lot CodeUDI: 00724995245047
- Serial Numbers
RL25293001RL25301003RL25301004RL26007031RL26013044RL26013045RL26028062RL26040066RL26054029RL26062001RL26063005RL26063007RL26063013RL26063014RL26063019RL26063021RL26063022RL26063023RL26069033RL26069034RL26072049RL26072052RL26072053RL26072055RL26072056RL26072056RL26077072RL26077073RL26077074RL26083077RL26084078RL26084080RL26084081RL26085083RL26085084RL26085085RL26085086RL26085087RL26085088RL26085089RL26089090RL26089091RL26089092RL26089093RL26089094RL26089095RL26089096RL26089097RL26098098RL26104099RL26105102RL26133103RL26133104RL26138105RL26139106RL26140114RL26187116RL26243121
- Amount recalled
- 58 systems
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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