Agency classClass IIOur severity:High FDA (Devices)·Z-0164-2020·Announced 2019-10-30

Rifton TRAM Standard Base Recalled for Latch Mechanism Fatigue Failure Risk

Community Products, LLC is recalling 3,282 Rifton TRAM Standard Base powered lift devices due to a design defect that may cause the latch mechanism to fail after repeated use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (fatigue failure of load-bearing components) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Community Products, LLC is recalling 3,282 units of the Rifton TRAM Standard Base, SKU K310, powered lift device. The recall was initiated because a design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use.

The affected products were distributed nationwide in the United States and worldwide, including Canada, the United Kingdom, Germany, Japan, Singapore, South Korea, the United Arab Emirates, Taiwan, Denmark, Italy, Hong Kong, Ireland, Australia, New Zealand, Israel, Colombia, and Russia. The recall covers specific units identified by ID codes beginning with K310, with dates ranging from 2012 to 2016.

Consumers should stop using the affected Rifton TRAM Standard Base devices immediately. The fatigue failure of the latch mechanism springs could compromise the safety of the lift. Users should contact Community Products, LLC for instructions on how to proceed with the recall.

The recalled product

Product: Rifton TRAM Standard Base, SKU K310, powered lift device
Manufacturer: Community Products, LLC
Category: Medical Device — Mobility Aid
Hazard: structural-failure
fall-risk
Affected units: 3,282

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Community Products, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Community Products, LLC

See all →

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Rifton TRAM Low Base Lift Device Recalled for Buckle Fatigue Failure
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Same hazard · structural failure