--- title: "Elekta Instrument AB Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Elekta Instrument AB recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/elekta-instrument-ab/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Elekta Instrument AB recall records **3** reported ongoing 3 records in this archive. Latest source date Sep 25, 2024. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Sep 25, 2024 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 f...](https://isitonrecall.com/recall/fda-device-z-0227-2025-elekta-disposable-biopsy-needle-kit-for-leksell-stereotactic-system-ref-911933-diameter-14-gauge-con/) 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 ... Class I Reported ongoing Distribution: US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA, [Official source for Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Ga...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0227-2025%22) Mar 15, 2024 FDA device enforcement ### [Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle...](https://isitonrecall.com/recall/fda-device-z-1397-2024-elekta-disposable-biopsy-needle-kit-for-leksell-stereotactic-system-ref-911933-2-1mm-diameter-14-gau/) Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) 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 h... Class I Reported ongoing Distribution: US and Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland [Official source for Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter /...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1397-2024%22) Mar 1, 2023 FDA device enforcement ### [Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Par...](https://isitonrecall.com/recall/fda-device-z-1309-2023-instructions-for-use-for-the-following-leksell-stereotactic-system-and-leksell-neurosurgical-instrum/) The incorrect IFU was distributed with the devices. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AZ, CA, CO, FL, GA, ID, IL, KS, MA, MD, MI, MN, MO, MS, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. There was... [Official source for Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Inst...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1309-2023%22) ## Reasons in these listed records - 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. - Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) 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... - The incorrect IFU was distributed with the devices. These examples come from this result page and are not a ranking of every recall reason. ## Checking Elekta Instrument AB ### Is there a recall on elekta instrument ab right now? This archive contains 3 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Elekta Instrument AB](https://isitonrecall.com/check/?q=Elekta%20Instrument%20AB) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)