Elekta recalls disposable biopsy needle kits for Leksell stereotactic systems due to potential microscopic stainless steel debris inside needles. This could cause injury during medical procedures. Affected kits have specific model numbers and batch codes.
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.
Elekta is recalling disposable biopsy needle kits for Leksell stereotactic systems because they may contain microscopic stainless steel debris inside the needles. This debris could cause injury during medical procedures if the needles are used as intended.
The needles may have microscopic stainless steel debris inside, which is made of the same material as the needle itself. This debris could potentially cause injury during medical procedures if the needles are used without proper inspection.
Medical professionals using Elekta's Leksell stereotactic systems for brain procedures are most at risk. Patients receiving these procedures may also be affected if the needles are used without proper checks.
Check for the model number REF 911933 on the outer packaging. The kit includes 6 needles and comes with a Tyvek bag labeled REF 912465. The batch number is 873874875R.
Inspect the needles for microscopic stainless steel debris inside the needle shaft.
The recall states that microscopic stainless steel debris may be inside the needles, but no debris has been found on the outer parts. This could pose a low risk of injury during medical procedures.
The official recall does not specify a remedy, so you should check for debris inside the needles and contact Elekta for further guidance.
Look for the model number REF 911933 on the outer packaging. The kit includes 6 needles and comes with a Tyvek bag labeled REF 912465. The batch number is 873874875R.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-0227-2025 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0227-2025 from Elekta. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
