Solar GI System — Class II medical device recall Z-2669-2026
Ongoing recall by Laborie Medical Technologies Corp, reported 2026-07-08, distributed nationwide. Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic
| Recall number | Z-2669-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Laborie Medical Technologies Corp, Portsmouth, NH, United States |
| Recall initiated | 2026-05-21 |
| Classified | 2026-07-02 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, CA, CH, CN, CR, CY, CZ, DE, DK, EG, ES, FR, GB, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, KR, KW, LB, LK, LT, MY, NL, NP, OM, PK, PL, PT, QA, RS, RU, SA, SI, TH, TN, TR, TW, VN, ZA |
| Quantity | 372 units |
| UPC / GTIN / UDI-DI | 08717775955047, 08717775955054, 08717775955061, 08717775955078, 08717775955085 |
| Model numbers | G3-12, G3-14, G3-6, G3-7, G3-8 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2669-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.