Medcare Floor Lifts Recalled Due to Potential Pin Failure
ErgoSafe Product LLC is recalling Medcare Floor Lifts manufactured between 2010 and 2012 because a design pin may break over time.
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 involves a medical device with a structural defect (pin breakage) that poses a risk of harm to patients during lifting or transfer, but no injuries or illnesses have been reported in the source text.
Plain-English summary
ErgoSafe Product LLC dba Prism Medical Services is recalling 514 units of Medcare Floor Lifts (models 400003 and 400013) and Scale Hanger Assemblies (model 400600). The affected units were manufactured between September 1, 2010, and November 7, 2012.
The recall was initiated because the original design includes a pin that may stop performing as designed and may break after years of use. The company determined that these units do not meet their high standards. The affected products were distributed nationwide in the states of CA, CO, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, NO, NE, NH, NY, ND, OH, OK, OR, PA, SD, TX, and WI.
Consumers should check their serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a unit is affected, users should stop using the lift and contact the recalling firm for instructions on repair or replacement.
The recalled product
- Product
- 400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift, transfer or position clients.
- Manufacturer
- ErgoSafe Product LLC dba Prism Medical Services
- Category
- Medical Device — Patient Lifts
- Affected units
- 514
Distribution
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