Z-2466-2015Class II

Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with...

Name: Z-2466-2015 Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with...
Creator: Sunrise Medical (US) LLC
Published: 2015-07-27
License: https://open.fda.gov/license/

Sunrise Medical, Inc. / initiated 2015-07-27 / Terminated / root cause: design

FDA source

Sunrise Medical (US) LLC began a recall of Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons... on 2015-07-27. FDA classified it as Class II and gives the reason as "Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant". 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-2466-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-27
Posted: 2015-08-26
Terminated: 2015-12-10
Recalling firm: Sunrise Medical, Inc.
Product: Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
Product code: IOR Wheelchair, Mechanical
Reason for recall: Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.
Root cause tag: design
FDA root cause: Device Design
Action: Sunrise Medical sent an Urgent Medical Device Field Correction letter dated July 27, 2015, to all affected dealers. The letter identified the product, the problem, and the action to be taken by the dealer. Dealers were instructed to immediately contact their customers to make arrangements to have the correction made with a replacement kit which will be supplied by Sunrise Medical to each dealer. Each dealer is requested to send back to Sunrise Medical the Acknowledgment and Response Form(s) by fax, email or regular mail once the work is completed. Customers with questions were instructed to contact Sunrise Medical Regulatory Affairs at (888) 208-4901.
Quantity in commerce: 64 total wheelchairs, both models
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Australia, Germany and Canada.
Product codes and lots: Model EIZ51, serial number range - ZRS-042132 to ZRS-042157.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2466-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2466-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-26
Z-2467-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-26

Product code IOR

K123975Class IQuickie & Zippie SeriesSunrise Medical / cleared 2013-08-16

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)