Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. Recalled by Hologic, Inc Due to Breach in sterile barrier compromising product sterility
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 Hologic, Inc directly.
Affected Products
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
Quantity: 600 units (US) ; 24 units (OUS)
Why Was This Recalled?
Breach in sterile barrier compromising product sterility
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hologic, Inc
Hologic, Inc has 24 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report