FDA Class II Device Recall - Raz-AT Mobile Shower Commode Chair
Summary
The FDA has issued a Class II device recall for Raz Design Inc.'s Raz-AT (Attendant Tilt) and Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chairs. The recall is due to a vendor modification that may lead to improper seat bracket engagement, posing a risk to users. Distribution was nationwide across multiple states.
What changed
The FDA has initiated a Class II device recall (Z-1498-2026) for Raz Design Inc.'s Raz-AT and Raz-ART Mobile Shower Commode Chairs. The recall stems from a vendor modification that could result in the seat brackets not being properly engaged, compromising the stability of the seat. This issue affects units distributed nationwide across several states, including CO, FL, IL, MA, MI, MN, MO, NC, NE, NH, NJ, NY, OR, PA, TX, WA, and WI.
Healthcare providers and consumers in possession of the affected chairs should be aware of the potential safety risk. While the document does not specify a compliance deadline for corrective actions, affected parties should consult Raz Design Inc. for guidance on addressing the defect. Failure to properly address device recalls can lead to regulatory scrutiny and potential harm to patients.
What to do next
- Review inventory for affected Raz-AT and Raz-ART Mobile Shower Commode Chairs.
- Consult Raz Design Inc. for instructions on addressing the recalled product.
- Notify affected customers or patients about the recall.
Source document (simplified)
Raz Design Inc
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1498-2026 · 20260318 · Ongoing
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 UD...
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.
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.
Source: openFDA Enforcement API
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