Class II — Potential Health Hazard

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

OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT Recalled by Angiodynamics, Inc. Due to May result in readings outside of the expected...

Date: November 19, 2019
Company: Angiodynamics, Inc.
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 Angiodynamics, Inc. directly.

Affected Products

OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.

Quantity: 160 units

Why Was This Recalled?

May result in readings outside of the expected accuracy range.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Angiodynamics, Inc.

Angiodynamics, Inc. has 74 total recalls tracked by RecallDetector.

Related Recalls

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