Elekta Disposable Biopsy Needle Kit for Leksell… recallZ-0227-2025 · Elekta Instrument AB · initiated Sep 25, 2024
Class I Open, Classified All recalls posted in November 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta Instrument AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0227-2025
- Recall class
- Class I (most serious)
- Status
- Open, Classified
- Initiated by the company
- Sep 25, 2024
- Posted by the FDA
- Nov 6, 2024
- Recalling firm
- Elekta Instrument AB
- Quantity
- 111 kits (666 needles)
- Product code
- HAW
- FDA submissions
- K152558
- Distribution
- US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
16 devices cleared under K152558 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Leksell Stereotactic System 1002248Elekta Instrument AB · Neurological stereotaxic Instrument1 recall3 reports
- Leksell Stereotactic System Neurosurgical Instruments A2800-15Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 907801Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments A2200-01Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments A2600-01Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments A2800-26Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 60377-01Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 60377-02Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 50376-01Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 50398-01Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 14001050Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 307165Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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