FDA recall Z-1138-2026

Community Products, LLC · Class II · device

Product

Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that the legs fit underneath beds.

Reason for recall

Potential for fraying on the body support strap.

Distribution

Worldwide distribution - US Nationwide and the countries of UAE, Australia, Canada, EU, Israel, Hong Kong, Japan, Korea, New Zealand, Russia, Saudi Arabia, and UK.

Key facts

Status
Ongoing
Initiation date
2025-12-18
Report date
2026-01-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rifton, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1138-2026