Class II — Potential Health Hazard

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

BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium Recalled by Bard Brachytherapy, Inc. Due to Bard Medical Division is recalling the BARD¿ BrachySource¿...

Date: April 10, 2018
Company: Bard Brachytherapy, 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 Bard Brachytherapy, Inc. directly.

Affected Products

BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource¿ Seed Implants absorbs the electrons.

Quantity: 70 Seeds at 0.28mCi and 100 seeds at 0.36mCi

Why Was This Recalled?

Bard Medical Division is recalling the BARD¿ BrachySource¿ Iodine125 Radioactive Seeds in Mick¿ Applicators and BARD¿ BrachySource¿ Iodine125 Radioactive Seeds Loose in Vial with Sterile Spacers. Because the incorrect dosage level radioactive seeds were mixed up and sent to two hospitals. One Hospital ordered BrachySource¿ Iodine125 0.36 mCi radioactive seeds but instead received BrachySource¿ Iodine125 0.28 mCi radioactive seeds and vice versa for the other hospital affected.

Where Was This Sold?

US Distribution to the states of : California and Georgia

About Bard Brachytherapy, Inc.

Bard Brachytherapy, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

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