Z-2157-2021Class II

Zippie Voyage, early intervention stroller -

Name: Z-2157-2021 Zippie Voyage, early intervention stroller -
Creator: Sunrise Medical (US) LLC
Published: 2021-07-08
License: https://open.fda.gov/license/

Sunrise Medical, Inc. / initiated 2021-07-08 / Terminated / root cause: design

FDA source

Sunrise Medical (US) LLC began a recall of Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing... on 2021-07-08. FDA classified it as Class II and gives the reason as "The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2157-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-08
Posted: 2021-07-28
Terminated: 2025-03-28
Recalling firm: Sunrise Medical, Inc.
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.
Product code: INM Chair, With Casters
Reason for recall: The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
Root cause tag: design
FDA root cause: Device Design
Action: On 07/12/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification informing customers that if the seating system is not adequately attached to the stroller base, the seating system may slide off the base and fall to the ground potentially causing injury a child. The Recalling Firm will be providing a safety tether and are informing/instructing their customers to: This Safety Tether Kit will be provided free of charge to all consumers starting the week of July 12, 2021. The Safety Tether Kit will be accompanied by instructions to guide consumers through installing and using the safety tether. The attached consumer communication template letter provide the consumer with three options until their Safety Tether Kit is received and the safety tether has been installed by them: 1. Choose to stop using the ZIPPIE Voyage early intervention stroller until a Safety Tether Kit has been provided and the safety tether has been installed by the consumer. OR 2. If they can elect to continue to use the early intervention stroller (before receiving their Safety Tether Kit and having installed the safety tether) and they can order their stroller with a transit option, they can use the transit strap to securely attach the stroller seat to the stroller handle. The transit strap may function to prevent the seat, if inadequately attached to the stroller base, from falling to the ground. However, the transit strap is not intended to be a replacement for the Safety Tether Kit that we will be providing. The tether set should be installed and used once it is received. OR 3. Experienced users who do not have the transit option on their stroller and choose to continue to use the stroller (before they receive their Safety Tether Kit and have installed the safety tether), must ensure that the stroller seat is securely attached to the stroller base before every use (following the instructions shown in the Owners Manual]). These steps must be performed each and every time the seat
Quantity in commerce: 9,865 devices
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, Australia, Hong Kong, Japan, Qatar, Norway, United Arab Emirates, China, Saudi Arabia, Sweden, Switzerland, Spain, Indonesia, India, Singapore, Bahrain and Israel.
Product codes and lots: Model Numbers: EIZ16; EIZ18; GTIN Number: 00016958053647 Serial Numbers: ZV1-007000-ZV1-016036; ZV18-000001-ZV18-002220; and ZV18-02062

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2157-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2157-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-28
Z-2158-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-28

Product code INM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)