Z-1595-2024Class II

SW Bari Lift & Transfer, Model Number 38060000

Name: Z-1595-2024 SW Bari Lift & Transfer, Model Number 38060000
Creator: Raye's Inc.
Published: 2024-01-25
License: https://open.fda.gov/license/

Agiliti Health - Hays / initiated 2024-01-25 / Open, Classified / root cause: design

FDA source

Raye's Inc. began a recall of SW Bari Lift & Transfer, Model Number 38060000 on 2024-01-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1595-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-25
Posted: 2024-04-18
Recalling firm: Agiliti Health - Hays
Product: SW Bari Lift & Transfer, Model Number 38060000
Product code: FNG Lift, Patient, Ac-Powered
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.
Root cause tag: design
FDA 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 in commerce: 1,149 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, UK.
Product codes and lots: UDI/DI 00845699001040, All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1595-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1595-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-18

Product code FNG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)