ClearanceBrief
Recall Z-1498-2026 ยท INN Chair, Adjustable, Mechanical

Raz Design Inc

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 Z2

DateMar 6, 2026 (initiated Jan 5, 2026)
StatusOpen, Classified
ReasonDue 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.
Root causeUse error
ActionOn 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
Quantity66
DistributionU.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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.