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# Electa Instrument Recalls Biopsy Needle Kits
- URL: https://www.fdaweb.com/electa-instrument-recalls-biopsy-needle-kits/
- Published: 2024-11-07T12:00:00.000Z
- Updated: 2026-09-14T14:46:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158145

Elekta Instrument AB has recalled (Class 1) its Elekta Disposable Biopsy Needle Kit for the Leksell Stereotactic System, which is used for localization and diagnosis of intracranial disorders and their surgical treatment, including radiosurgery and stereotactic radiation therapy. “Elekta has become aware that the Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle,” a [recall notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=210361&ref=fdaweb.com) says. The material in the debris is stainless steel, which it says is the same material as the biopsy needle, adding that no debris has been found on the outer parts of the needles.

Elekta has issued an “Urgent Important Field Safety Notification” to its consignees that instructs them to destroy the affected products.