SW Bari Lift & Transfer, Model Number 38060000 recallZ-1595-2024 · Raye's Inc. · initiated Jan 25, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Raye's Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.
FDA root cause category: Device Design
What the company is doing
Sizewise Manufacturing issued an URGENT Voluntary Medical Device Recall to its consignees on 01/29/2024 by letter. The notice explained the issue, potential risk, and requested the discontinuation of use and disposal of the device. The firm sent a follow-up notice on 03/07/2024 asking the distributors to further notify their customers (users of the device).
Recall details
- Recall number
- Z-1595-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 25, 2024
- Posted by the FDA
- Apr 18, 2024
- Recalling firm
- Raye's Inc.
- Quantity
- 1,149 units
- Product code
- FNG
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, UK.
Product description
SW Bari Lift & Transfer, Model Number 38060000
Code information (models, lots, serial numbers)
UDI/DI 00845699001040, All serial numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Portable Overhead Lift LIFTOHSizewise Rentals, L.L.C. · Lift, Patient, Ac-Powered1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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