Z-1138-2026Class II
Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for...
Community Products, LLC / initiated 2025-12-18 / Open, Classified
Community Products, LLC began a recall of 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... on . FDA classified it as Class II and gives the reason as "Potential for fraying on the body support strap". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1138-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Community Products, LLC
- 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.
- Product code
- FSA Lift, Patient, Non-Ac-Powered
- Reason for recall
- Potential for fraying on the body support strap.
- FDA root cause
- Process change control
- Action
- Community Products notified consignees via email on about 12/18/2025. Consignees were instructed to notify all customers, if further distributed, of the recall, inspect all affected devices for visible fraying, and cease use if any is observed. Consignees were requested to provide contact information for the individual responsible for performing the replacement. If devices were further distributed, consignees were advised to manage all customer outreach, inspection and replacement. The other option was to provide Community Products with customer contact information, and Rifton will manage the process. Lastly, consignees were requested to confirm receipt of the notification.
- Quantity in commerce
- 1,096 units
- 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.
- Product codes and lots
- Model/Catalog Number: K320. ID Codes: K32020130515AA, K32020130603AA, K32020130606AA, K32020130607AB, K32020130610AA, K32020130612AA, K32020130617AA, K32020130617AB, K32020130618AA, K32020130709AA, K32020130713AA, K32020130713AB, K32020130717AB, K32020130802AA, K32020130805AA, K32020130807AA, K32020130808AA, K32020130808AB, K32020130812AA, K32020130812AB, K32020130812AC, K32020130812AD, K32020130813AA, K32020130814AA, K32020130820AA, K32020130822AA, K32020130823AA, K32020130824AA, K32020130827AA, K32020130827AB, K32020130828AA, K32020130830AA, K32020130907AA, K32020130909AB, K32020130909AC, K32020130909AD, K32020130909AE, K32020130919AA, K32020130920AA, K32020130924AA, K32020131007AA, K32020131007AB, K32020131009AA, K32020131017AB, K32020131021AA, K32020131022AB, K32020131022AC, K32020131022AD, K32020131024AA, K32020131025AA, K32020131029AA, K32020131031AA, K32020131101AA, K32020131102AA, K32020131107AA, K32020131115AD, K32020131119AA, K32020131120AD, K32020131205AA, K32020131210AA, K32020131217AD, 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K32020200810AA, K32020200810AB, K32020201023AB, K32020141101AA, K32020160727AA, K32020160727AB, K32020140121AC, K32020141118AC, K32020150110AA, K32020150220AA, K32020150306AB, K32020150319AB, K32020150724AA, K32020150923AA, K32020151124AB, K32020151125AA, K32020151226AA, K32020151226AB, K32020151226AC, K32020151226AD, K32020160223AA, K32020160224AA, K32020161103AA, K32020161111AA, K32020161112AA, K32020170407AA, K32020170407AB, K32020170407AC, K32020170812AA, K32020170812AB, K32020170812AC, K32020170814AA, K32020170814AB, K32020180313AA, K32020180313AB, K32020190510AA, K32020190511AA, K32020190512AA, K32020190513AA, K32020190513AB, K32020200303AA, K32020200629AB, K32020200629AC, K32020200629AD, K32020141118AA, K32020190422AB, K32020190422AC, K32020190422AD, K32020190621AA, K32020190621AB, K32020191125AC, K32020191218AA, K32020201016AA, K32020201026AA.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1137-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1138-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1139-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.