L'Islet, Canada
Umano Medical, Inc. recalls
2 recalls recorded since 2018, most recently on 11 April 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 April 2022
- Terminated
- 17 January 2024
- Reason
- There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, PA, AL, GA, AZ, MN, FL, WA, OK, NY, ND, AR, MO, NC, UT, TX, WI, and the countries of Australia, Ireland, and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1135-2022, Z-1136-2022
- AC-powered adjustable medical beds with built-in electric DC actuators and controls.
- AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Terminated Class II Medical devices
- Recall started
- 4 May 2020
- Terminated
- 30 December 2020
- Reason
- Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.
- Distribution
- Domestic distribution: AR, CA, FL, GA, UT, MS, NY, PA International distribution: Australia, Brasil, Canada and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2205-2020
- AC Powered hospital adjustable bed.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.