Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ARROW OnControl Bone Lesion Biopsy System Tray Recalled by Teleflex Medical Due to Sterility: Due to a potential incomplete seal on...

Date: November 8, 2016
Company: Teleflex Medical
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Teleflex Medical directly.

Affected Products

ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.

Why Was This Recalled?

Sterility: Due to a potential incomplete seal on the outer sterile package.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Teleflex Medical

Teleflex Medical has 204 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report