The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0264-2022·Announced 2021-11-24

Permobil TiLite wheelchairs recalled for improper vehicle restraint

Permobil TiLite wheelchairs (Models Aero Z and ZRA) used as vehicle passenger seats may not be properly oriented during motor vehicle accidents due to transit tie-down configuration issues. Consumers should discontinue use as passenger seats until replacement tie-downs are installed.

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: This is an FDA Class II recall for a medical device with potential for serious injury in motor vehicle accidents. No illnesses or injuries have been reported, and the hazard is conditional and theoretical, making this a high-risk product where injury has not yet been reported.

Plain-English summary

Permobil TiLite wheelchairs (Models Aero Z and ZRA) are being recalled. When used as passenger seats in motor vehicles, some affected wheelchairs may not be configured in the proper orientation to perform safely in a motor vehicle accident.

As a result, affected wheelchairs can no longer be used as passenger seats until the transit tie-down system is replaced with redesigned components that are properly verified and released to the market.

5,373 wheelchairs are affected by this recall. The affected units were manufactured between January 19, 2017 and June 14, 2021 and have been distributed nationwide in the United States as well as in Australia, Canada, France, Germany, Ireland, Italy, the United Kingdom, Uruguay, New Zealand, and Sweden.

Consumers who own an affected wheelchair should discontinue use as a vehicle passenger seat immediately and contact the manufacturer (TiSport, LLC) for information about obtaining replacement transit tie-downs and verification that the unit can be safely returned to service.

The recalled product

Product
Permobil TiLite, Models: Aero Z, and ZRA
Manufacturer
TiSport, Llc
Category
Medical Device — Wheelchair
Hazard
Affected units
5,373

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 (3)

  • Manufactured between January 19
  • 2017 and June 14
  • 2021 with the serial number range from M2005054 to 1231112011

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Related recalls

Same manufacturer · TiSport, Llc

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