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Incident · Recall

FDA Class 2 recall of Epione needle guide component due to rust

Quantum Surgical issued an urgent field safety notice for 2 Epione units in Florida after discovering rust on a component (central axis) inside the Needle Guide product (product number 02-0027). The affected units were returned, repaired, and replaced. Recall was completed by October 2024.

Occurred 2024-08-05 · Epione · Quantum Surgical · Surgical robots · 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 Epione needle guide component due to rust

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Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=209707

Status history

  • Active · 2026-07-06 · agent:depth

Common questions

What happened in FDA Class 2 recall of Epione needle guide component due to rust?
Quantum Surgical issued an urgent field safety notice for 2 Epione units in Florida after discovering rust on a component (central axis) inside the Needle Guide product (product number 02-0027). The affected units were returned, repaired, and replaced. Recall was completed by October 2024.
When did this incident occur?
The incident is recorded as occurring on August 5, 2024 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 Epione needle guide component due to rust?
Epione by Quantum Surgical is the recorded robot involved in this incident.
Has anyone responded to FDA Class 2 recall of Epione needle guide component due to rust?
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 Epione needle guide component due to rust?
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 Epione needle guide component due to rust.

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Canonical ID 622ce5ab-b136-479d-8631-33ec3aa0491e