Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool Recalled by Butterfly Network, Inc. Due to Distributed without an approved 510(k)
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 Butterfly Network, Inc. directly.
Affected Products
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of anatomical structures.
Quantity: 11,183
Why Was This Recalled?
Distributed without an approved 510(k)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Butterfly Network, Inc.
Butterfly Network, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report