Butterfly Network, Inc. Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
Brand
Butterfly Network, Inc.
Lot Codes / Batch Numbers
Software versions 1.13.0, 1.14.0, and 1.15.0 UDI: (01)00866646000206
Products Sold
Software versions 1.13.0, 1.14.0, and 1.15.0 UDI: (01)00866646000206
Butterfly Network, Inc. is recalling Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentati due to Distributed without an approved 510(k). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Distributed without an approved 510(k)
Recommended Action
Per FDA guidance
Butterfly Network issued a correction notification via email on February 24, 2020 disabling the Auto Bladder Volume Tool from affected devices operating software versions 1.13.0, 1.14.0 and 1.15.0 for all affected US Butterfly iQ customers and removed references of Auto Bladder Volume Tool from outward marketing platforms. Butterfly Network has notified Affiliate partners to cease marketing the Auto Bladder Volume Tool until further notice. Questions related to this correction can be sent to Butterfly Network Customer Support via email at Support@butterflynetwork.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026