Hill-Rom Manufacturing, Inc. CLINITRON CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CLINITRON CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.
Brand
Hill-Rom Manufacturing, Inc.
Lot Codes / Batch Numbers
All serial numbers.
Products Sold
All serial numbers.
Hill-Rom Manufacturing, Inc. is recalling CLINITRON CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer developm due to Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
Recommended Action
Per FDA guidance
Hill-Rom issued an "Urgent Field Safety Notice" letter dated February 2, 2009 addressed to Facility Risk Managers and Facility Administrators. The notice detailed the issue and instructed users on actions to be taken. For further information, please contact Hill-Rom Customer Service at 1-800-638-2546.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026