The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1595-2024·Announced 2024-04-24

SW Bari Lift & Transfer Device Recalled Due to Weight and Safety Defects

Raye's Inc. is recalling the SW Bari Lift & Transfer (Model 38060000) due to two critical defects: it cannot safely support its maximum rated weight, and it lacks a safety mechanism to prevent falls during a single equipment failure.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II device with documented structural safety defects (weight-bearing failure and lack of fall-prevention mechanism). No hospitalizations or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Raye's Inc. is recalling the SW Bari Lift & Transfer, Model Number 38060000, a lifting and transfer device designed for people with disabilities. The recall affects 1,149 units distributed worldwide, including the United States, Australia, and the United Kingdom.

Engineering analysis has identified two critical safety defects in the device. First, it cannot physically perform at its maximum documented weight specifications when a proper factor of safety is applied. Second, the device is not equipped with a safety mechanism to prevent a person from falling in the event of a single-fault condition.

Facilities and individuals using this device should contact Raye's Inc. for information about safe continued use or replacement options.

The recalled product

Product
SW Bari Lift & Transfer, Model Number 38060000
Manufacturer
Raye's Inc.
Affected units
1,149

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 00845699001040
  • All serial numbers

Distribution

Distributed nationwide across the United States.

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