Williston, VT, United States
LABORIE MEDICAL TECHNOLOGIES, CORP recalls
2 recalls recorded since 2018, most recently on 21 May 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 May 2026
- Reason
- 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.
- 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, Leban
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2669-2026
- 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
Terminated Class II Medical devices
- Recall started
- 17 July 2019
- Terminated
- 10 July 2023
- Reason
- Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard
- Distribution
- US distribution in AZ, and PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2076-2019
- U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.