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Incident · Recall

Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft

Intuitive recalled the Ion Flexision 19G Biopsy Needle (REF 490104-09 / -10) because the sheath tip could separate from the sheath shaft. 1,625 units. Source: FDA Class 2 device recall Z-0106-2022, openFDA enforcement / accessdata.fda.gov.

Occurred 2021-08-06 · Intuitive Surgical · Investigated by FDA

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Track Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft

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Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=188906

Common questions

What happened in Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft?
Intuitive recalled the Ion Flexision 19G Biopsy Needle (REF 490104-09 / -10) because the sheath tip could separate from the sheath shaft. 1,625 units. Source: FDA Class 2 device recall Z-0106-2022, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on August 6, 2021 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft?
The incident is recorded as involving Intuitive Surgical on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft?
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 Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft?
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 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

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 Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft.

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