TiLite Aero ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853316008006), received between Jul 22, 2025 and Jul 22, 2025 — classified as 1 malfunction.

3 other recalls cover devices cleared under the same FDA submission (K990358); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS "BACK CANES" (LIKELY BACKREST) BREAKING, CAUSING END USER TO FALL OUT OF THE CHAIR AND BREAK ARM.

  Patient problems: Limb Fracture

  MAUDE report 22569279 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990358. One submission often covers many models, so check the product and lot details in each record.

• Z-0264-2022 · Sep 24, 2021 · Open, Classified
  Permobil TiLite, Models: Aero Z, and ZRA
• Z-2294-2019 · Sep 11, 2018 · Terminated
  TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs).
• Z-3161-2011 · Jul 5, 2011 · Terminated
  TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model c