Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System — Class I medical device recall Z-1397-2024
Ongoing recall by Elekta Instrument AB, reported 2024-04-24. Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some mi
| Recall number | Z-1397-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Instrument AB, Stockholm, Sweden |
| Recall initiated | 2024-03-15 |
| Classified | 2024-04-16 |
| Reported by FDA | 2024-04-24 |
| Countries outside the US | AT, AU, BE, CH, DE, ES, FR, GR, IT, NL, SE |
| Quantity | 601 needles |
| Reason classes | sterility |
| Lot numbers | 837838839 |
| Model numbers | 2.1MM, 911761, 911933, 912465 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1397-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.