Sit to Stand STS500 Patient Lift Recalled Due to Loose Boom Fasteners
Med-Mizer is recalling 37 units of the Sit to Stand STS500 Patient Lift due to risk of boom pivot failure caused by a loose securing nut and unsecured bolt on the boom flange.
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 device with a structural defect (loose fasteners risking boom pivot failure) in a patient mobility device. The source explicitly reports no illnesses or injuries, and the hazard is currently theoretical. Per the rubric, structural risk-of-harm products without reported injuries score at most 3.
Plain-English summary
Med-Mizer, Inc. is recalling 37 units of the Sit to Stand STS500 Patient Lift. The recalled lifts have a defect in which the nut securing the boom can become loose and the bolt can become unsecure to the flange on the side, creating a risk that the boom pivot may fail.
A failing boom pivot could result in loss of structural integrity of the lift and potential patient injury. No illnesses or injuries have been reported to date.
The affected lifts can be identified by the UDI-DI 00852195007353 and serial numbers STS500000 through STS500036. Med-Mizer is contacting known consignees and working to retrieve affected devices. If you have one of these lifts, stop using it and contact Med-Mizer for instructions on return or replacement.
The recalled product
- Product
- Sit to Stand STS500 Patient Lift
- Manufacturer
- Med-Mizer, Inc.
- Category
- Medical Device — Patient Lift
- Hazard
- boom-pivot-failure
- loose-fastener
- structural-failure
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: 00852195007353
- Serial No.: STS500000
- STS500001
- STS500002
- STS500003
- STS500004
- STS500005
- STS500006
- STS500007
- STS500008
- STS500009
- STS500010
- STS500011
- STS500012
- STS500013
- STS500014
- STS500015
- STS500016
- STS500017
- STS500018
Distribution
Distribution scope not specified by the agency.
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