TiLite TiLite ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00853316008136), received between Jan 12, 2026 and Aug 11, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Mechanical Problem; Structural Problem

  Received report while end-user was using their device, the frame broke just above the caster wheels which caused the end-user to lose positioning and fall to the ground. Reports indicate the end-user sustained an injury, but unclear if medical intervention was sought.

  Patient problems: Laceration(s)

  MAUDE report 50213842 ↗
• InjuryJan 12, 2026Mechanical Problem; Detachment of Device or Device Component

  RECEIVED REPORT CLAIMING WHILE MANEUVERING THE MANUAL WHEELCHAIR ON A DOWNHILL GRADE ON A NEIGHBORHOOD STREET, REPORTS THE SOLID TIRE OF THE RIGHT WHEEL BECAME DETACHED FROM THE RIM. THIS REPORTEDLY CAUSED THE END-USER THE INABILITY TO STOP THE FORWARD MOMENTUM AND FORCED THE END-USER TO JUMP OUT OF THE SEATING IN ORDER TO AVOID A COLLISION WITH AN IMMOVABLE OBJECT. REPORT INDICATES WHEN THE END-USER CHOSE TO EVACUATE THE SEATING TO THE GROUND, THEY SUSTAINED AN INJURY REQUIRING MEDICAL INTERVENTION TO ADDRESS.

  Patient problems: Abrasion; Bone Fracture(s)

  MAUDE report 24045159 ↗

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