Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number Recalled by Shape Medical Systems, Inc Due to This recall has been initiated because use of...
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 Shape Medical Systems, Inc directly.
Affected Products
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
Quantity: 564 devices
Why Was This Recalled?
This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for VO2 or VCO2 parameters could be approximately 20% with use of the impacted product.
Where Was This Sold?
This product was distributed to 10 states: AZ, FL, GA, MA, MN, NJ, NY, PA, TX, WI
About Shape Medical Systems, Inc
Shape Medical Systems, Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report