Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spiegelberg Brain Pressure Monitoring System Probe 3PN Recalled by Spiegelberg Gmbh & Co. KG Due to In the vast majority of products specified, a...
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 Spiegelberg Gmbh & Co. KG directly.
Affected Products
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
Quantity: 22 units
Why Was This Recalled?
In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg. The observed measurement error was particularly at the lowest end of the range (to 0 mmHg) up to 8 mmHg.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Spiegelberg Gmbh & Co. KG
Spiegelberg Gmbh & Co. KG has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report