TiLite ZRARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00853316008051), received between Aug 4, 2025 and Nov 25, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER'S FRONT WHEELS "HIT THE ASPHALT" AND FELL FORWARD OUT OF THE CHAIR, RESULTING IN A BROKEN HIP AND 1 MONTH OF HOSPITALIZATION.

  Patient problems: Bone Fracture(s); Hip Fracture

  MAUDE report 23648808 ↗
• InjuryOct 15, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  END USER WAS GOING DOWN A CUT OUT IN THE SIDEWALK. WHEEL HIT A RAISED PIECE OF CEMENT AND THE CHAIR STOPPED. END USER FELL OUT OF THE CHAIR, BROKE LEG.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 23302785 ↗
• InjuryAug 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  END USER REPORTS THAT ONE OF THE REAR WHEELS CAME OFF OF HER WHEELCHAIR. THIS RESULTED IN HER FALLING, END USER'S BACK IMPACTED THE AXLE PIN OF THE WHEEL. END USER'S CATHETER WAS PULLED OUT AS A RESULT OF THIS FALL.

  Patient problems: Fall

  MAUDE report 22709722 ↗

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