FDA Medical devices recall ·
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0227-2025
- Date
- (initiated September 25, 2024)
- Company / brand
- Elekta Instrument AB
Kungstensgatan 18, Stockholm, N/A, Sweden - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 111 kits (666 needles)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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 Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch Number 873874875R Package including 6 needles: UDI: (01)0 7340048 30034 6 (17) 260301 (10) 873874875R (240) 911933 Package including 1 needle: UDI: (01)0 7340048 30800 7 (17) 260301 (10) 873874875R (240) 911761 Inner sterile bag including 1 needle: UDI: (01)0 7340048 30801 4 (17) 260301 (10) 873874875R (240) 912465
Distribution
US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,
States: Arizona California Florida Georgia Missouri New Jersey New York Pennsylvania Texas Virginia Washington
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0227-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.