High FDA (Devices)·Z-1204-2023·Announced 2023-03-08

Med-Riser MR600 Patient Lift Boom Pivot Failure Risk Recall

Med-Mizer, Inc. is recalling the Med-Riser MR600 Patient Lift due to risk that the boom pivot may fail if the securing nut loosens and the bolt becomes unsecured. Contact the manufacturer for instructions.

What this means for you

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 recall for a patient handling device with a structural failure risk. No injuries, illnesses, or deaths have been reported. The hazard involves fastener looseness that could cause the boom pivot to fail, meeting the rubric criterion for Score 3 (High): a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Med-Mizer, Inc. is recalling the Med-Riser MR600 Patient Lift. The recall affects 241 units and is due to a structural risk involving the boom pivot mechanism.

According to the manufacturer, the nut securing the boom may become loose, and the bolt may become unsecured to the flange on the side. This creates a risk of the boom pivot failing.

Facilities and care providers using the affected Med-Riser MR600 units should contact Med-Mizer, Inc. for guidance on their devices.

Serial numbers affected range from MR600000 through MR600240.

The recalled product

Product: Med-Riser MR600 Patient Lift
Manufacturer: Med-Mizer, Inc.
Category: Medical Device — Patient Lift / Mobility Assistance
Hazard: structural-failure
fastener-looseness
Affected units: 241

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 (20)

UDI-DI: 00852195007308
Serial No.: MR600000
MR600001
MR600002
MR600003
MR600004
MR600005
MR600006
MR600007
MR600008
MR600009
MR600010
MR600011
MR600012
MR600013
MR600014
MR600015
MR600016
MR600017
MR600018

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Med-Mizer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Med-Mizer, Inc.

See all →

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Same hazard · structural failure