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Incident · Recall

FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance

Butterfly Network issued a correction notification after distributing the Auto Bladder Volume Tool without an approved 510(k). The action affected 15,121 host devices in US distribution. Butterfly disabled the tool via software update and removed marketing references.

Occurred 2020-02-24 · Butterfly AI Ultrasound · Butterfly Network · Biometric wearables · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance

Machine-readable surfaces

Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=180229

Status history

  • Active · 2026-07-03 · agent:depth

Common questions

What happened in FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance?
Butterfly Network issued a correction notification after distributing the Auto Bladder Volume Tool without an approved 510(k). The action affected 15,121 host devices in US distribution. Butterfly disabled the tool via software update and removed marketing references.
When did this incident occur?
The incident is recorded as occurring on February 24, 2020 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance?
Butterfly AI Ultrasound by Butterfly Network is the recorded robot involved in this incident.
Has anyone responded to FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-07-21

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-21

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance.

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Canonical ID 19ebb31c-6dce-4fe0-90eb-f98cb3a8d8bf