Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fetal Spiral Electrode Recalled by Philips North America, LLC Due to During use of the Philips FSE, it is...
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 Philips North America, LLC directly.
Affected Products
Fetal Spiral Electrode, Model No. 9898 031 37631
Quantity: 1,971,925 (78,877 boxes)
Why Was This Recalled?
During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips North America, LLC
Philips North America, LLC has 88 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report