Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of Recalled by KCI USA, Inc. Due to The firm is initiating a voluntary medical device...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact KCI USA, Inc. directly.
Affected Products
RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
Quantity: 282 units
Why Was This Recalled?
The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About KCI USA, Inc.
KCI USA, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report