| | Class 2 Device Recall Raz Mobile Shower Commode Chair |  |
| Date Initiated by Firm | January 05, 2026 |
| Date Posted | March 06, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1498-2026 |
| Recall Event ID |
98254 |
| Product Classification |
Chair, adjustable, mechanical - Product Code INN
|
| 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. |
| Code Information |
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:
RAS210872
RAS214903
RAS217818
RAS220760
RAS209166
RAS218239
RAS107030
RAS214470
Raz-AP (Attendant Propel) Mobile Shower Commode Chair
Catalog Number Z100
Seat Catalog Numbers:
ZVFIFAR17
ZVFIFAR 20
ZCSEAT (FAR)
UDI-DI code: (01)00628758001003
Serial Numbers:
RAS217210
RAS224711
RAS214364
FAR Seat (Demo)
Catalog Numbers:
ZVFI17FAR-A
ZCSEAT-A
UDI-DI code: N/A
Serial Numbers: N/A |
| FEI Number |
3006055387
|
Recalling Firm/ Manufacturer |
Raz Design Inc 82 Carnforth Rd North York Canada
|
Manufacturer 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 2 | Use error |
| 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 arahat@razdeigninc.com
|
| Quantity in Commerce | 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. |
| Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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