Elekta Biopsy Needle Kit (Elekta) – Microscopic Debris (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.
Brand
Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Batch Number 873874875R Package including 6 needles: UDI: (01)0 7340048 30034 6 (17) 260301 (10) 873874875R (240) 911933 Package including 1 needle: UDI: (01)0 7340048 30800 7 (17) 260301 (10) 873874875R (240) 911761 Inner sterile bag including 1 needle: UDI: (01)0 7340048 30801 4 (17) 260301 (10) 873874875R (240) 912465
Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden is recalling Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge due to Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the deb. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Elekta issued an URGENT IMPORTANT FIELD SAFETY NOTIFICATION to its consignees on 069/23/2023 via email. Then notice explained the problem, clinical impact, and requested the destruction of the affected product. Contact the local Elekta representative for alternative solutions. They also requested that the notice be posted in a place accessible to all users until this action is closed and to notify all appropriate personnel working with this product of the content of the notice.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, GA, MO, NJ, NY, PA, TX, VA, WA
Page updated: Jan 10, 2026