Elekta recalls disposable biopsy needle kits with lot 837838839 for possible microscopic stainless steel debris inside needles. No sterility issues reported. Affected kits contain 6 inner boxes labeled REF 911761.
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.
Elekta is recalling disposable biopsy needle kits that may contain microscopic stainless steel debris inside the needles. This could potentially cause injury if the debris punctures tissue during medical procedures. The recall affects kits with specific lot numbers and model references.
The needles from a specific batch (lot 837838839) may have microscopic stainless steel debris inside. This debris is made of the same material as the needle itself. While the debris is only inside the needle and not on the outer surface, it could potentially cause injury if the needle punctures tissue during medical procedures.
Medical professionals using Elekta's biopsy needle kits for stereotactic procedures are most at risk. Patients receiving these needles during procedures may be affected if the debris causes injury.
Look for kits labeled REF 911933, 2.1mm diameter / 14 gauge, with lot number 837838839 on the labels. Each kit contains 6 inner boxes labeled REF 911761 with Tyvek bags labeled REF 912465.
Look for lot number 837838839 on the labels for REF 911933, REF 911761, and REF 912465.
The recall reports possible microscopic stainless steel debris inside needles from one batch, but no injuries have been reported. The debris is only inside the needle and not on the outer surface.
Check for lot number 837838839 on the labels for REF 911933, REF 911761, and REF 912465.
The recall does not specify a remedy, so no action is required beyond checking the labels.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-1397-2024 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-1397-2024 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.
