Sunrise Medical Recalls Quickie and Zippie IRIS Wheelchairs with MONO Backrest
Sunrise Medical is recalling 64 Quickie and Zippie IRIS wheelchairs because the MONO Backrest System may break, posing a risk of falls or injury to the occupant.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect that poses a risk of harm (fall or injury) to the user, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sunrise Medical (US) LLC is recalling 64 Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs. The affected units are model EIZ5A in combination with option code 188M02, which includes the MONO Backrest System with the Dynamic Backrest option. These devices are designed to provide mobility to persons limited to a sitting position.
The recall is being issued because the MONO Backrest System with Dynamic Backrest may break over time. This failure could result in a fall or injury to the occupant of the wheelchair.
The affected wheelchairs were distributed worldwide, including nationwide in the United States and internationally to Australia, Germany, and Canada. Consumers with these specific models should contact Sunrise Medical (US) LLC for further instructions on how to address the defect.
The recalled product
- 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.
- Manufacturer
- Sunrise Medical (US) LLC
- Category
- Medical Device — Mobility Aids
- Affected units
- 64
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model EIZ51
- serial number range - ZRS-042132 to ZRS-042157.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Sunrise Medical (US) LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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