FDAFDA recall Z-2669-2026 · Jul 8, 2026
Laborie Medical Technologies Corp: Solar GI System (Water Perfusion) recall
Recall found
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, Trolley system (G3-14);
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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;
- Quantity
- 372 units
- Distribution
- 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.
- Recalling firm
- Laborie Medical Technologies Corp, Portsmouth, NH
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-21
Source: openFDA enforcement record Z-2669-2026 · search recall number Z-2669-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.