# FDA recall Z-1595-2024

> **Raye's Inc.** · Class II · device recall initiated 2024-01-25.

## Product

SW Bari Lift & Transfer, Model Number 38060000

## Reason for recall

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.

## Key facts

- **Recall number:** Z-1595-2024
- **Recalling firm:** Raye's Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-25
- **Report date:** 2024-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hays, KS, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1595-2024

## Citation

> AI Analytics. FDA recall Z-1595-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1595-2024. Source: US FDA. Licensed CC0.

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