FDA Medical Device Recalls (openFDA)
Raye's Inc.: SW Bari Lift & Transfer, Model Number 38060000
- Recall number
- Z-1595-2024
- Recalling firm
- Raye's Inc.
- Product
- SW Bari Lift & Transfer, Model Number 38060000
- Status
- Open, Classified
- Initiated
- 2024-01-25
- Posted
- 2024-04-18
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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).
- Quantity
- 1,149 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, UK.
- Lot, serial or model codes
- UDI/DI 00845699001040, All serial numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNG
- Firm FEI
- 1931307
- Firm city
- Hays
- Firm state
- KS
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28