Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AxoTrack I Sterile Procedure Kit 18G Recalled by Soma Access Systems LLC Due to There is a possibility the sterile packaging may...
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 Soma Access Systems LLC directly.
Affected Products
AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.
Quantity: 3530 units
Why Was This Recalled?
There is a possibility the sterile packaging may fail before the expiration date specified on the package.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Soma Access Systems LLC
Soma Access Systems LLC 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