Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MY01 Continuous Compartmental Pressure Monitor Recalled by MY01, INC. Due to There is an incorrect version of the needle...
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 MY01, INC. directly.
Affected Products
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Quantity: 37 units
Why Was This Recalled?
There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufactured using needles with a needle trocar geometry which is out of specification and may require a slightly higher push force from the user to penetrate the patient skin.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About MY01, INC.
MY01, INC. 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