Hays, KS, United States
Raye's Inc. recalls
1 recall recorded since 2018, most recently on 25 January 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 January 2024
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1595-2024
- SW Bari Lift & Transfer, Model Number 38060000
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.