FDAFebruary 24, 2020device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Distributed without an approved 510(k)
What to do
FDA enforcement status: Terminated
Brands named
butterfly networkbutterfly
UPCs
00866646000206
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCKingPavonini Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by KingPavonini2025-11-26
- CPSCJuvo Plus Recalls Children's Butterfly Net Sets and Army Action Figure Playsets Due to Violations of Federal Phthalates and Lead Content Bans (Recall Alert)2022-10-20
- FDAMatrix Clinical Solution At-Home COVID-19 Test2022-01-24
- CPSCEarth Sonnets Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)2020-03-18
- FDAButterfly 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 ...2020-02-24
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- FDATestosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL2016-09-21
- FDANicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectable, Compounded by Wells Pharmacy, Ocala, FL2016-09-21
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