Umano Medical Recalls AC Powered Hospital Adjustable Beds
Umano Medical is recalling 3,259 AC powered hospital adjustable beds due to a potential hazard of unsupervised patients falling out of bed.
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 medical device that poses a risk of patient falls, which aligns with the rubric criteria for Severe severity (FDA Class II with significant injury risk).
Plain-English summary
Umano Medical, Inc. is recalling 3,259 AC powered hospital adjustable beds. The recall involves Model FL36 beds with serial numbers OL360011P or OL360017P. These products were distributed domestically in Arkansas, California, Florida, Georgia, Utah, Mississippi, New York, and Pennsylvania, as well as internationally in Australia, Brazil, Canada, and the United Kingdom.
The recall was initiated because of a potential hazard where an unsupervised patient could be out of the bed, leading to a potential patient fall. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities and consumers who possess these specific beds should contact Umano Medical, Inc. for instructions on how to proceed with the recall. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AC Powered hospital adjustable bed.
- Manufacturer
- Umano Medical, Inc.
- Category
- Medical Device — Hospital Bed
- Hazard
- Affected units
- 3,259
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 (1)
- Model FL36 Numbers OL360011P or OL360017P
Distribution
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