Device recall: Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is…
Class II FDA enforcement event 66896. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sunrise Medical (US) LLC started this device recall on 11 Nov 2013. The firm address in the FDA record is in Fresno, CA. FDA put the recall in Class II. FDA event 66896 has 1 product record. The first FDA enforcement report date is 11 Dec 2013. The record gives the status Terminated, with the termination date 18 Mar 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Hong Kong, and China.
Recalling firm
Sunrise Medical (US) LLC, Fresno, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0453-2014 | Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting. | 316 units in US, 29 units international | Class II | Terminated | 11 Dec 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2013
- 1,236
- Share of these events in Class II
- 90%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Jul 2021 | Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assistin | Device | Class II | 2 |
| 13 Feb 2020 | Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power | Device | Class II | 1 |
| 1 Jul 2016 | Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mo | Device | Class II | 1 |
| 27 Jul 2015 | Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest | Device | Class II | 2 |
| 19 Dec 2014 | Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. | Device | Class II | 2 |
| 26 Jun 2012 | Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0453-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 66896. https://recallregister.com/fda/ii/66896/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Hong Kong, and China.
- What quantity of product is in FDA event 66896?
- The FDA record gives this quantity:
316 units in US, 29 units international
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 90% of the 1,236 device events that started in 2013 are in Class II.