FDA Recalls Medcare Max-500 Patient Lifts Due to Potential Load Failure
Ergosafe Products LLC is recalling 97 Medcare Max-500 patient stands because the lift might fail with 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a patient lift that could cause significant injury if the equipment fails under load.
Plain-English summary
Ergosafe Products LLC DBA Prism Medical Services USA is recalling 97 units of the Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The product is used for assisting patients or residents to a standing position. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN.
The recall was initiated because the lift might fail with the labeled 500-lb. load rating. This defect poses a risk of injury to patients or caregivers if the equipment fails during use.
The affected units were distributed nationwide. Consumers and healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice and stop using the affected units immediately.
The recalled product
- Product
- Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. 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
- 97
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 0109STH0042
- 0112STH0085
- 0112STH0086
- 0112STH0087
- 0112STH0089
- 0112STH0090
- 0112STH0091
- 0112STH0092
- 1211STH0071
- 0207STH0003
- 0207STH0004
- 0209STH0043
- 0211STH0072
- 0212STH0093
- 0212STH0094
- 0212STH0095
- 0212STH0096
- 0212STH0097
- 0212STH0098
- 0212STH0099
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 →- HighFDA Recalls Medcare Max-500 Patient Stands Due to Load Failure Risk
FDA (Devices) · 2013-11-27
Same hazard · structural failure
See all →- High
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