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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Elekta Instrument AB
Distribution
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