Elekta Disposable Biopsy Needles Recalled for Internal Debris Contamination
Elekta recalls disposable biopsy needles for the Leksell Stereotactic System due to microscopic stainless steel debris found inside the needles. 111 kits (666 needles) distributed across multiple U.S. states are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum Severe rating per the rubric. The recall involves potential sterility compromise of single-use medical devices used in surgical procedures.
Plain-English summary
Elekta Instrument AB is recalling Disposable Biopsy Needle Kits (REF 911933, 14 Gauge) for use with the Leksell Stereotactic System, which is used for diagnosis and treatment of intracranial disorders. The recall affects Batch Number 873874875R.
Microscopic stainless steel debris has been found on the inside of some biopsy needles, while no debris appears on the exterior surfaces. This internal contamination could compromise the sterility of the devices.
The recall affects 111 kits containing 666 needles that were distributed to healthcare facilities across the United States, including Arizona, Texas, Florida, California, New York, Georgia, Virginia, New Jersey, Missouri, Pennsylvania, and Washington.
Healthcare facilities in possession of affected kits should stop using them immediately and contact Elekta for replacement product. The FDA has classified this as a Class I recall due to the potential risk of non-sterile instruments in surgical procedures.
The recalled product
- 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,
- Manufacturer
- Elekta Instrument AB
- Hazard
- contamination
- sterility-compromise
Distribution
Distributed in 11 states:
- AZ
- CA
- FL
- GA
- MO
- NJ
- NY
- PA
- TX
- VA
- WA
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03