Class II — Sunrise Medical (US) LLC
| Recalling firm | Sunrise Medical International Inc. |
|---|---|
| Registered facility | SUNRISE MEDICAL INTERNATIONAL INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. |
| Product | 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 a child or small adult not to exceed 75 pounds. |
| Quantity | 4,741 device |
| 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. The countries of United Kingdom, Germany, France, Canada, Italy, Netherlands, Poland, Czech Republic, … |
| Initiated | 2021-07-08 |
| Classified | 2021-07-28 |
| Terminated | 2025-03-28 |
| Recall number | Z-2158-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sunrise Medical (US) LLC (Z-2158-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88257/
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