CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report

Solar GI System (Water Perfusion) recalled

Laborie Medical Technologies is recalling Solar GI System (Water Perfusion), distributed nationwide in the US. The recall was initiated on 21 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 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; Basic UDI-DI: 87177759500G3G8; All serial numbers; 3. Catalog Number: G3-8; UDI-DI: Primary UDI-DI: 08717775955061; Basic UDI-DI: 87177759500G3G8; All serial numbers; 4. Catalog Number: G3-12; UDI-DI: Primary UDI-DI: 08717775955078; Basic UDI-DI: 87177759500G3G8; All serial numbers; 5. Catalog Number: G3-14; UDI-DI: Primary UDI-DI: 08717775955085; Basic UDI-DI: 87177759500G3G8; All serial numbers;

Quantity recalled372 units

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-2669-2026
FDA event ID: 98876
Recalling firm: Laborie Medical Technologies, Portsmouth, NH
Classification: Class II
Status: Ongoing
Recall initiated: 21 May 2026
FDA classified: 2 Jul 2026
Reported: 8 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

21 May 2026	Recall initiated by company
2 Jul 2026	Classified by FDA	+42 days
8 Jul 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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, Trolley system (G3-14);

Where it was distributed

Worldwide distribution - US Nationwide and the countries of 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, Osterreich, Pakistan, Poland, Portugal, Puerto Rico, Qatar, Russia, Russian Federation, Saudi Arabia, Serbia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, United Kingdom, and Vietnam.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

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; Basic UDI-DI: 87177759500G3G8; All serial numbers; 3. Catalog Number: G3-8; UDI-DI: Primary UDI-DI: 08717775955061; Basic UDI-DI: 87177759500G3G8; All serial numbers; 4. Catalog Number: G3-12; UDI-DI: Primary UDI-DI: 08717775955078; Basic UDI-DI: 87177759500G3G8; All serial numbers; 5. Catalog Number: G3-14; UDI-DI: Primary UDI-DI: 08717775955085; Basic UDI-DI: 87177759500G3G8; All serial numbers;

Where was it sold?

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 Laborie Medical Technologies

All 2

Reported	Class	Recall	Company	Reason	Where
31 Jul 2019Device	CLASS II	U3-3 Solar Blue, Laptop integrated power supply used recalled	Laborie Medical Technologies	Device Malfunction	AZ, PA

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