FDA Recall Open, Classified

Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene.

Recall: Z-1498-2026 · Initiated January 5, 2026

Recall

Recall Number
Z-1498-2026
Event Number
98254
Firm
Raz Design Inc
FEI Number
3006055387
Product Code
INN
Status
Open, Classified
Root Cause
Use error
Initiated
January 5, 2026
Posted
March 6, 2026
Address
82 Carnforth Rd, North York Canada

Description

Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene.

Reason

Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.

Action

On 01/05/2025, the firm email an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them that an incident was reported to Raz involving a Raz Mobile Shower Commode Chair with a certain Front and Rear Open (FAR) Seat. This incident in Canada involved an unauthorized modification of a FAR seat by a vendor, followed by reinstallation without properly engaging the outside rear seat brackets that keep the seat in place. This is not a supported configuration, and it resulted in one side of the seat halves slipping off the seat frame, which caused an injury to the user. Customers are instructed to: 1 Notify impacted customers using this Correction Notice and request that they return the Acknowledgement and Receipt Form to you. 2 Raz will provide items to facilitate Correction. The items will be provided directly to the Sales Rep or to Dealer, whichever will execute the Correction action: 3 Sales Rep or Dealer shall conduct a service visit with the impacted end-user. For users/caregivers: 1 Be sure that the FAR seat is properly installed and latched before a user is transferred onto the chair. The rear seat attachment bracket must be fully hooked under the rear seat support tube(s). The front seat attachment brackets must be securely latched around the front seat support tubes. Both front and rear seat attachment brackets should be secured in place by tightening the 8 screws on the underside of the seat. 2 if seat needs to be removed for cleaning, follow instructions as per User & Dealer Manual proper removal and installation of the seat to ensure safe use of the chair prior to the installation of the FAR Seat Retrofit Kit. 3 If you do not have a User and Dealer Manual, download a copy from www.razdesigninc.com, or contact Sales Rep or Dealer. For questions or further assistance - contact Raz Design Inc by email at [email protected]

Distribution

U.S. Nationwide distribution in the states of CO, FL, IL, MA, MI, MN, MO, NC, NE, NH, NJ, NY, OR, PA, TX, WA, and WI.

Quantity

66