Elekta Disposable Biopsy Needle Kit for Leksell… recallZ-1397-2024 · Elekta Instrument AB · initiated Mar 15, 2024
Class I Open, Classified All recalls posted in April 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 (911933) from one batch (837838839) 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. The sterility of the biopsy needles has not been affected. This issue has been reported from one site.
FDA root cause category: Under Investigation by firm
What the company is doing
Elekta issued an URGENT RECALL NOTIFICATION to its consignees on 03/05/2024 via email. The notice explained the problem, potential risk, and requested that the consignee advise appropriate personnel and destroy the affected product.
Recall details
- Recall number
- Z-1397-2024
- Recall class
- Class I (most serious)
- Status
- Open, Classified
- Initiated by the company
- Mar 15, 2024
- Posted by the FDA
- Apr 16, 2024
- Recalling firm
- Elekta Instrument AB
- Quantity
- 601 needles
- Product code
- HAW
- FDA submissions
- K152558
- Distribution
- US and Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland
Product description
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm 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.
Code information (models, lots, serial numbers)
Lot number 837838839 appears on the labels for REF 911933, REF 911761, and REF 912465. UDI numbers: REF 911933 - (01)0 7340048 30034 6, (17)250401 (10) 837838839 (240) 911933; REF 911761 - (01)0 7340048 30800 7, (17)250401 (10) 837838839 (240) 911761; REF 912465 - (01)0 7340048 30801 4, (17)250401 (10) 837838839 (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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