Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported November 13, 2024
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.
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Elekta Instrument Ab recalled Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diamete… - a critical-severity action.
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diamete… was recalled by Elekta Instrument Ab in November 13, 2024. Reason: Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of t…. Check the official notice for the remedy. Verify recall #Z-0227-2025 with the FDA Devices before acting.
The recall
Elekta Instrument Ab issued this critical-severity FDA Devices recall-Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of t….
- Critical
- severity level
- Class I
- classification
- November 13, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0227-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0227-2025) was formally reported on November 13, 2024, with the manufacturer initiating the action on September 25, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Elekta Instrument Ab is listed as the recalling firm, operating out of Stockholm, N/A. Federal records list the affected scope as 111 kits (666 needles).
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
111 kits (666 needles)
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0227-2025 |
| Date reported | November 13, 2024 |
| Date initiated | September 25, 2024 |
| Recalling firm | Elekta Instrument Ab |
| Firm location | Stockholm, N/A |
| Affected scope | 111 kits (666 needles) |
| Distribution | US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA, |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0227-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Elekta Instrument Ab. Units affected: 111 kits (666 needles).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2024. Severity: Critical. Recall number: Z-0227-2025.
Where was the recalled product distributed? ▼
Distribution: US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0227-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 13, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.