Product Wiki · Recalls · U.S. FDA — Device Enforcement

Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System… — recall Z-0227-2025

U.S. FDA — Device Enforcement · Sweden · 2024-09-25 · Class I

As described by U.S. FDA — Device Enforcement: Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 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 N

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0227-2025
Date of alert
2024-09-25
Country / jurisdiction
Sweden
Risk level
Class I
Notice type
recall
Brand
Elekta Instrument AB
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,
Reported risk: 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.
What to do

Check whether your product matches this notice (name, batch, dates). If it does, stop using it and follow the instructions in the official notice — refund, return, repair or disposal are set by the issuing authority and the business, and they differ per recall. Official notice from U.S. FDA — Device Enforcement →

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.