Incident · Recall
Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage
Auris Health recalled the Monarch Aspirating Biopsy Needle (REF MBR-000012) after reports of needle breakage. 158 units. Source: FDA Class 2 device recall Z-0025-2020, openFDA enforcement / accessdata.fda.gov.
Occurred 2019-04-19 · Auris Health · Investigated by FDA
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Common questions
What happened in Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage?
Auris Health recalled the Monarch Aspirating Biopsy Needle (REF MBR-000012) after reports of needle breakage. 158 units. Source: FDA Class 2 device recall Z-0025-2020, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on April 19, 2019 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage?
The incident is recorded as involving Auris Health on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage?
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 Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage?
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.
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Canonical ID c1f9d75c-99c1-483e-ae90-b58ba27f1bad