Fresno, CA, United States
Sunrise Medical (US) LLC recalls
2 recalls recorded since 2018, most recently on 8 July 2021. 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
- 8 July 2021
- Terminated
- 28 March 2025
- Reason
- The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Th
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2157-2021, Z-2158-2021
- Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for
- Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for
Terminated Class II Medical devices
- Recall started
- 13 February 2020
- Terminated
- 28 April 2021
- Reason
- Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits.
- Distribution
- Distributed to US Consignee in MT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1947-2020
- Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966).
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.