CLASS II Device recall · Reported 4 Aug 2021 · FDA Enforcement Report
Zippie Voyage, early intervention stroller recalled
Sunrise Medical (US) is recalling Zippie Voyage, early intervention stroller, distributed nationwide in the US. The recall was initiated on 8 Jul 2021 and the FDA has classified it as Class II.
Check your package
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-2158-2021
- FDA event ID
- 88257
- Recalling firm
- Sunrise Medical (US), Fresno, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jul 2021
- FDA classified
- 28 Jul 2021
- Reported
- 4 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 8 Jul 2021 | Recall initiated by company | |
| 28 Jul 2021 | Classified by FDA | +20 days |
| 4 Aug 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
Product as listed by the FDA
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.
Where it was distributed
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, Australia, Hong Kong, Japan, Qatar, Norway, United Arab Emirates, China, Saudi Arabia, Sweden, Switzerland, Spain, Indonesia, India, Singapore, Bahrain and Israel.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Is Zippie Voyage, early intervention stroller recalled?
Yes. Sunrise Medical (US) recalled Zippie Voyage, early intervention stroller on 8 Jul 2021. The recall is Class II and its status is Terminated. Recall number Z-2158-2021.
Why was it recalled?
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
Which lots are affected?
Model Numbers: EIZ14; Serial Numbers: ZV-001340 through ZV-006153
Where was it sold?
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, Australia, Hong Kong, Japan, Qatar, Norway, United Arab Emirates, China, Saudi Arabia, Sweden, Switzerland, Spain, Indonesia, India, Singapore, Bahrain and Israel.
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 21 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 Sunrise Medical (US)
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|---|---|---|---|---|---|
| Device | CLASS II | Zippie Voyage, early intervention stroller recalled | Sunrise Medical (US) | Other | Nationwide |
| Device | CLASS II | Quickie/Zippie powered wheelchair recalled by Sunrise Medical (US) | Sunrise Medical (US) | Device Malfunction | MT |
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