Recall Z-1498-2026
Raz Design Inc · initiated January 5, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Raz-AT (Attendant Tilt) Mobile Shower Commode Chair Catalog Number Z300 Seat Catalog Numbers: ZVFIFAR17 ZVFIFAR20 ZCSEAT (FAR) UDI-DI code: (01)00628758003007 Serial Numbers: RAT218789 RAT116906 RAT200337 RAT208010 RAT208987 RAT210426 RAT211344 RAT211837 RAT211998 RAT212001 RAT212066 RAT212450 RAT213190 RAT213227 RAT214334 RAT217987 RAT218213 RAT218552 RAT218570 RAT218612 RAT219142 RAT220066 RAT222210 RAT223140 RAT224902 RAT206923 RAT217768 RAT221724 RAT213036 RAT218862 RAT221044 RAT216437 RAT217073 RAT218555 RAT218557 RAT219817 RAT121348 RAT216055 RAT217379 RAT220648 RAT124264 RAT200864 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair Catalog Number Z333 Seat Catalog Numbers: ZVFIFAR17 ZVFIFAR20 ZCSEAT (FAR) UDI-DI code: (01)00628758003335 Serial Numbers: ART219556 ART222544 ART211605 ART223825 ART212722 ART212675 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair Catalog Number Z360 Seat Catalog Numbers: ZCSEATHD (FAR) UDI-DI code: (01)00628758003601 Serial Numbers: BAT216618 BAT204112 Raz-SP (Self Propel) Mobile Shower Commode Chair Catalog Number Z200 Seat Catalog Numbers: ZVFIFAR17 ZVFIFAR20 ZCSEAT (FAR) UDI-DI code: (01)00628758001003 Serial Numbers:…
Reason for recall
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.
FDA-determined cause: Use error
Action taken
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 arahat@razdeigninc.com
Details
- Recall number
- Z-1498-2026
- Initiated
- January 5, 2026
- Posted by FDA
- March 6, 2026
- Product code
- INN – Chair, Adjustable, Mechanical
- Quantity
- 66
- 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.
- Recalling firm
- Raz Design Inc, North York