CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report

AC Powered hospital adjustable bed recalled by Umano Medical

Umano Medical is recalling AC Powered hospital adjustable bed, distributed in 8 states. The recall was initiated on 4 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel FL36 Numbers OL360011P or OL360017P

Quantity recalled3259 beds

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2205-2020
FDA event ID: 85592
Recalling firm: Umano Medical, L'Islet, N/A
Classification: Class II
Status: Terminated
Recall initiated: 4 May 2020
FDA classified: 2 Jun 2020
Reported: 10 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 May 2020	Recall initiated by company
2 Jun 2020	Classified by FDA	+29 days
10 Jun 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.

Product as listed by the FDA

AC Powered hospital adjustable bed.

Where it was distributed

Domestic distribution: AR, CA, FL, GA, UT, MS, NY, PA International distribution: Australia, Brasil, Canada and United Kingdom.

Arkansas California Florida Georgia Mississippi New York Pennsylvania Utah

Questions about this recall

Why was it recalled?

Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.

Which lots are affected?

Model FL36 Numbers OL360011P or OL360017P

Where was it sold?

Domestic distribution: AR, CA, FL, GA, UT, MS, NY, PA International distribution: Australia, Brasil, Canada and United Kingdom.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Umano Medical

All 3

Reported	Class	Recall	Company	Reason	Where
1 Jun 2022Device	CLASS II	AC-powered adjustable medical beds recalled by Umano Medical	Umano Medical	Device Malfunction	Nationwide
1 Jun 2022Device	CLASS II	AC-powered adjustable medical beds recalled by Umano Medical	Umano Medical	Device Malfunction	Nationwide

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