Class II — Potential Health Hazard

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

Theragenics Applicator Needle (18g x 20cm) The device is comprised Recalled by Theragenics Corporation Due to Some of the pouches containing Brachytherapy Applicator Needles...

Date: October 9, 2018
Company: Theragenics Corporation
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 Theragenics Corporation directly.

Affected Products

Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.

Quantity: 480 packs (5 needles each)  NOTE: The multipacks are part of a box of 25 needles, containing five (5) single packs and four (4) 5-packs.

Why Was This Recalled?

Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Theragenics Corporation

Theragenics Corporation has 1 total recall tracked by RecallDetector.

Related Recalls

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