Official recall record

Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF

US FDA — Medical Devices · 2024-09-25 · SwedenClass I

Issuing authority: US FDA — Medical Devices
Alert date: 2024-09-25
Country of alert: Sweden
Alert level: Class I
Alert type: recall
Brand on record: Elekta Instrument AB

What the authority reported

Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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