Facility

BUTTERFLY NETWORK, INC.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010102386
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	1600 District Ave Burlington, MA, US 01803
Registration status	Active · expires 2026
Parent company	Butterfly Network, Inc. (owner-operator 10057531)
Brand names	Butterfly iQ; Butterfly iQ+

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (3)

Transducer, Ultrasonic, Diagnostic
Product code ITX (opens in a new tab) · Class II · Radiology · 21 CFR 892.1570
System, Imaging, Pulsed Doppler, Ultrasonic
Product code IYN (opens in a new tab) · Class II · Radiology · 21 CFR 892.1550
System, Imaging, Pulsed Echo, Ultrasonic
Product code IYO (opens in a new tab) · Class II · Radiology · 21 CFR 892.1560

Recalls & enforcement

Class IITerminated2020-02-24
Distributed without an approved 510(k)
Class IITerminated2020-02-24
Distributed without an approved 510(k)

FDA inspections (1)

NAI2021-10-01
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Butterfly Network, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BUTTERFLY NETWORK, INC. (FEI 3010102386) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010102386-butterfly-network-inc/

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