Reported Jul 8, 2026 · Ongoing
Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar…
Laborie Medical Technologies Corp.
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: Laborie Medical Technologies Corp · 180 International Dr · Portsmouth, NH · 03801-6837
Is this the product you have?
- Solar GI System (Water Perfusion)
- Product Name (Catalog Number)
Solar GI LGI H2O12pTrolley system (G3-6)Solar GI HRM H2O24pCompact Pole system (G3-7)Solar GI HRM H2O24pTrolley system (G3-8)Solar GI HRM H2O36pTrolley system (G3-12)Solar GI HRAM H2O24pTrolley system (G3-14)
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published G3-608717775955047UDI-DI: Primary UDI-DI: 08717775955047; Basic UDI-DI: 87177759500G3G8; All serial numbers G3-708717775955054UDI-DI: Primary UDI-DI: 08717775955054; Basic UDI-DI: 87177759500G3G8; All serial numbers G3-808717775955061UDI-DI: Primary UDI-DI: 08717775955061; Basic UDI-DI: 87177759500G3G8; All serial numbers G3-1208717775955078UDI-DI: Primary UDI-DI: 08717775955078; Basic UDI-DI: 87177759500G3G8; All serial numbers G3-1408717775955085UDI-DI: Primary UDI-DI: 08717775955085; Basic UDI-DI: 87177759500G3G8; All serial numbers - Amount recalled
- 372 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Under extended clinical use conditions (e.g., long duration studies), 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.
This product could cause temporary or reversible health problems — stop using it.
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