Use cautionMedical device recall · FDA · Published March 8, 2021
Arrow OnControl Bone Biopsy Tray Recall: Difficulty Inserting Ejector Rod
Arrow recalls OnControl Bone Lesion Biopsy System Tray (Product Code 9464-VC-006) due to difficulty inserting biopsy ejector rod, risking repeat procedures. Affected units sold in US/EU with specific lot numbers.
Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure
Take action
Contact the company
📍Recalling firmArrow International Inc2400 Bernville Rd · Reading, PA 19605-9607
“Arrow OnControl Bone Biopsy Tray Recall: Difficulty Inserting Ejector Rod.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63115-arrow-oncontrol-bone-biopsy-tray-recall-difficulty-inserting-ejector-rod. Based on FDA recall #Z-1374-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1374-2021%22&limit=1).
The FDA announced on March 8, 2021, that Arrow International Inc. is recalling the Arrow OnControl Bone Lesion Biopsy System due to a defect preventing sample collection. The agency said use of the device may require an immediate repeat biopsy.
How to tell if you have it
Brand: Arrow
Product: Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy
Product Code: 9464-VC-006 (US) and 9464-EU-001 (EU)
Lot Numbers US: 39647326, 39647327, 39647328, 40422734, 40422735, 38347967, 40422740
Lot Number EU: 40808740
Distribution: US Nationwide
The hazard
The FDA said the biopsy ejector rod may be difficult to insert into the cannula, preventing the collection of a bone lesion sample. The agency stated that use of a defective device is likely to require an immediate repeat biopsy, leading to a prolonged procedure.
Context
GovInfoNow's records show Arrow International Inc. has 52 other recalls on record since June 1, 2017. Other recent recalls include the Arrow Arterial Kits and Trays recall (July 26, 2024) regarding open packaging seals, the Arrow UltraFlex Intra-Aortic Balloon Catheter Kit recall (April 29, 2024), and the ARROW QuickFlash Radial Artery Catheter recall (Feb. 12, 2024). Other recent recalls of similar products include the Arrow Biopsy System Kits Recall (April 21, 2026) and the Arrow Access Tray Recall (April 21, 2026), both citing risks of serious injury from contaminated drugs or medication.
How to tell if you have this one
Check for Product Code 9464-VC-006 (US) or 9464-EU-001 (EU) with specific lot numbers listed in the recall notice. The device is used for bone biopsies of the vertebral body and bone lesions.
Brand
Arrow
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Code
Identify the product code on the device label: 9464-VC-006 for US units or 9464-EU-001 for EU units.
Contact Manufacturer
Reach out to Arrow International for specific guidance on whether your unit requires action.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1374-2021 (March 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1374-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.