The Recall Desk
ModerateFDA (Devices)·Z-2669-2026·Announced 2026-07-08

Solar GI System Water Perfusion Units Recalled Due to Moisture Accumulation

Laborie Medical Technologies is recalling Solar GI System (Water Perfusion) units worldwide because moisture may accumulate in internal tubing and filters under extended use, potentially affecting airflow and pressure measurement performance.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is performance degradation under extended use conditions, which is a moderate safety concern but not an acute or severe risk.

Plain-English summary

Laborie Medical Technologies Corp is recalling Solar GI System (Water Perfusion) units, including models Solar GI LGI H2O (Catalog G3-6), Solar GI HRM H2O (Catalogs G3-7, G3-8, G3-12), and Solar GI HRAM H2O (Catalog G3-14). A total of 372 units have been distributed worldwide, including across the United States and to Argentina, Australia, Austria, Bangladesh, Belgium, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Namibia, Nepal, Netherlands, Oman, Pakistan, Poland, Portugal, Puerto Rico, Qatar, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Under extended clinical use conditions, moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed.

The FDA has classified this as a Class II recall. Users with affected devices should contact Laborie Medical Technologies Corp for instructions on proper moisture management and maintenance procedures.

The recalled product

Product
Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p
Manufacturer
Laborie Medical Technologies Corp
Category
Medical Device — Gastrointestinal Diagnostic Equipment
Hazard
  • moisture-accumulation
  • performance-degradation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • 1. Catalog Number: G3-6
  • UDI-DI: Primary UDI-DI: 08717775955047
  • Basic UDI-DI: 87177759500G3G8
  • All serial numbers
  • 2. Catalog Number: G3-7
  • UDI-DI: Primary UDI-DI: 08717775955054
  • 3. Catalog Number: G3-8
  • UDI-DI: Primary UDI-DI: 08717775955061
  • 4. Catalog Number: G3-12
  • UDI-DI: Primary UDI-DI: 08717775955078
  • 5. Catalog Number: G3-14
  • UDI-DI: Primary UDI-DI: 08717775955085

Distribution

Distributed nationwide across the United States.

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