| | Class 2 Device Recall Rifton TRAM |  |
| Date Initiated by Firm | December 18, 2025 |
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| Date Posted | January 22, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1137-2026 |
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| Recall Event ID |
98140 |
| Product Classification |
Lift, patient, non-ac-powered - Product Code FSA
|
| Product | Rifton Equipment, TRAM. Model/Catalog Number: K310.
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. |
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| Code Information |
Model/Catalog Number: K310. ID Codes: K31020120704AA, K31020120706AA, K31020120707AC, K31020120707AD, K31020120707AE, K31020120707AG, K31020120709AA, K31020120709AB, K31020120709AD, K31020120709AE, K31020120710AB, K31020120710AE, K31020120711AB, K31020120712AA, K31020120713AB, K31020120713AC, K31020120713AD, K31020120713AF, K31020120718AA, K31020120718AB, K31020120718AC, K31020120719AC, K31020120720AA, K31020120801AA, K31020120804AB, K31020120804AD, K31020120804AH, K31020120804AI, K31020120806AA, K31020120806AC, K31020120806AD, K31020120806AE, K31020120806AG, K31020120806AH, K31020120806AI, K31020120806AL, K31020120806AM, K31020120806AN, K31020120806AO, K31020120807AA, K31020120807AB, K31020120807AC, K31020120807AE, K31020120807AF, K31020120809AD, K31020120809AE, K31020120810AC, K31020120813AB, K31020120814AA, K31020120814AB, K31020120814AC, K31020120816AA, K31020120816AC, K31020120816AD, K31020120817AB, K31020120817AC, K31020120820AC, K31020120820AD, K31020120821AA, K31020120821AB, K31020120821AC, 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Recalling Firm/
Manufacturer |
Community Products, LLC
2032 Route 213
Rifton NY 12471
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| For Additional Information Contact | Travis Scott
845-6587722 |
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Manufacturer Reason
for Recall | Potential for fraying on the body support strap. |
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FDA Determined
Cause 2 | Process change control |
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| 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. |
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| Quantity in Commerce | 3,238 units |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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