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Urgent Enforcement Amended Final

FDA Class II Device Recall - Raz-AT Mobile Shower Commode Chair

Favicon for changeflow.com FDA: Device Recalls Class II
Filed March 18th, 2026
Detected March 29th, 2026
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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

  1. Review inventory for affected Raz-AT and Raz-ART Mobile Shower Commode Chairs.
  2. Consult Raz Design Inc. for instructions on addressing the recalled product.
  3. 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

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 18th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1498-2026

Who this affects

Applies to
Healthcare providers Consumers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Device Recalls
Threshold
Class II device
Geographic scope
United States US

Taxonomy

Primary area
Product Safety
Operational domain
Compliance
Topics
Medical Devices Consumer Protection

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