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Open, Classified

SW Bari Lift & Transfer, Model Number 38060000

FDA Recall Z-1595-2024 · Posted 2024-04-18

Recalling FirmRaye's Inc.
Recall StatusOpen, Classified
Product CodeFNG
Date Initiated2024-01-25
Product Quantity1,149 units

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.

Firm 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).

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, UK.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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