FDA Recalls Medcare Max-500 Patient Stands Due to Load Failure Risk
Ergosafe Products LLC is recalling 233 Medcare Max-500 patient stands because the lift mechanism might fail under the labeled 500-lb load rating.
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: The recall is classified as FDA Class II, and the hazard involves a mechanical failure of a patient lift that could result in injury, but no specific injuries or fatalities are reported in the source text.
Plain-English summary
Ergosafe Products LLC DBA Prism Medical Services USA is recalling 233 units of the Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The product is used for assisting patients or residents to a standing position. The recall was initiated because the lift might fail with the labeled 500-lb. load rating.
The affected units were distributed nationwide. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. The recall covers specific serial numbers ranging from 0106SWH0008 to 1210SWH0147.
Consumers and healthcare facilities should stop using the affected patient stands immediately. Users should check the serial number of their device against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.
- Category
- Medical Device — Patient Lifts
- Affected units
- 233
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)
- Serial numbers 0106SWH0008
- 0106SWH0009
- 0106SWH0010
- 0107SWH0031
- 0107SWH0032
- 0107SWH0033
- 0107SWH0034
- 0108SWH0044
- 0108SWH0045
- 0109SWH0065
- 0109SWH0066
- 0109SWH0067
- 0109SWH0068
- 0109SWH0069
- 0109SWH0070
- 0109SWH0071
- 0111SWH0148
- 0111SWH0149
- 0111SWH0150
- 0111SWH0151
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ergosafe Products LLC DBA Prism Medical Services USA 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 →Related recalls
Same manufacturer · Ergosafe Products LLC DBA Prism Medical Services USA
See all →- SevereFDA Recalls Medcare Max-500 Patient Lifts Due to Potential Load Failure
FDA (Devices) · 2013-11-27
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