FDA Device recall Z-1595-2024
SW Bari Lift & Transfer, Model Number 38060000
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of SW Bari Lift & Transfer, Model Number 38060000 by Raye S, citing retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications whe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1595-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-25 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Raye S |
| Distribution | US |
Product
SW Bari Lift & Transfer, Model Number 38060000
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.
Identifiers
| code_info | UDI/DI 00845699001040, All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1595-2024%22
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