Elekta Instrument AB: Medical Device Recall in 2024 - (Recall #: Z-1397-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: March 15, 2024

Date Posted: April 24, 2024

Recall Number: Z-1397-2024

Event ID: 94197

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.

Status: Ongoing

Product Quantity: 601 needles

Code Information:

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.

Distribution Pattern:

US and Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland

Voluntary or Mandated:

Voluntary: Firm initiated