Butterfly Network, Inc.
2 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (2)
Registered facilities (1)
- BUTTERFLY NETWORK, INC. FEI 3010102386 · MA
Recalls & enforcement
- Class IITerminated2020-02-24Distributed without an approved 510(k)
- Class IITerminated2020-02-24Distributed without an approved 510(k)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Butterfly Network, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10057531-butterfly-network-inc/
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