Z-1397-2024Class I

Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge...

Name: Z-1397-2024 Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge...
Creator: Elekta Instrument AB
Published: 2024-03-15
License: https://open.fda.gov/license/

Elekta Instrument AB / initiated 2024-03-15 / Open, Classified / root cause: sterility

FDA source

Elekta Instrument AB began a recall of Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761... on 2024-03-15. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1397-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-03-15
Posted: 2024-04-16
Recalling firm: Elekta Instrument AB
Product: 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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: 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.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 601 needles
Distribution: US and Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1397-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1397-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-16

Product code HAW

K152558Class IILeksell Stereotactic System, Injection/ Aspiration Needle KitElekta Instrument AB / cleared 2016-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)