Pasco, WA, United States
TiSport, Llc recalls
2 recalls recorded since 2018, most recently on 24 September 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 September 2021
- Reason
- Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if involved in a motor vehicle accident. Some affected wheelchairs can no longer be used as a passenger seat until transit tie downs are replaced with redesigned transit tie downs, verified, and released to the market.
- Distribution
- US Nationwide Distribution: MD, PA, VA, IN, NY, MO, AR, NE, NJ, WA, NM, IL, CA, OH, KY, LA, OK, WI, TX, NC, SD, MN, MA, OR; OUS (Foreign): AUSTRALIA, CANADA, FRANCE, GERMANY, IRELAND, ITALY, UNITED KINGDOM, URUGUAY, NEW ZEALAND, IRELAND, SWEDEN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0264-2022
- Permobil TiLite, Models: Aero Z, and ZRA
Terminated Class II Medical devices
- Recall started
- 11 September 2018
- Terminated
- 29 July 2022
- Reason
- The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.
- Distribution
- Distribution was nationwide, including Puerto Rico. There was also government distribution but no military distribution. Foreign distribution was made to Canada, Australia, Brazil, China, Italy, Saudi Arabia, Switzerland, United Kingdom, and Uruguay.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2294-2019
- 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). Product Usage: The affected componen
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.