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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88257

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 08, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sunrise Medical (US) LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-2157-2021
Recall number
Z-2157-2021
Initiated
July 08, 2021
Classification
Class II
Status
Terminated
Recalling firm
Sunrise Medical (US) LLC
Quantity
9,865 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

Code information

Model Numbers: EIZ16; EIZ18; GTIN Number: 00016958053647 Serial Numbers: ZV1-007000-ZV1-016036; ZV18-000001-ZV18-002220; and ZV18-02062

Distribution pattern

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.

device · product 2 of 2

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.

Z-2158-2021
Recall number
Z-2158-2021
Initiated
July 08, 2021
Classification
Class II
Status
Terminated
Recalling firm
Sunrise Medical (US) LLC
Quantity
4,741 device

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

Code information

Model Numbers: EIZ14; Serial Numbers: ZV-001340 through ZV-006153

Distribution pattern

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.