Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clien
Summary
The FDA issued a Class II for Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a po by Community Products, LLC. Reason: Potential for fraying on the body support strap..
Details
Source
Device Recall
External ID
Z-1138-2026
Action Date
2026-01-28
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Model/Catalog Number: K320. 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Quantity Affected: 1,096 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-18
Company
Rifton, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Community Products, LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Community Products, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Community Products, LLC have FDA actions?
Community Products, LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1138-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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