Class II — Potential Health Hazard

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

BioSentry Tract Sealant System Recalled by Surgical Specialties Mexico S DE RL DE CV Due to Surgical Specialties Mexico is recalling the BioSentry Track...

Date: September 24, 2016
Company: Surgical Specialties Mexico S DE RL DE CV
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 Surgical Specialties Mexico S DE RL DE CV directly.

Affected Products

BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.

Quantity: 512 boxes (2560 units)

Why Was This Recalled?

Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.

Where Was This Sold?

This product was distributed to 20 states: AZ, CA, CO, CT, DE, FL, GA, ID, MA, NV, NH, NJ, NY, OH, OK, PA, TX, VT, VA, WA

Affected (20 states)Not affected

About Surgical Specialties Mexico S DE RL DE CV

Surgical Specialties Mexico S DE RL DE CV has 1 total recall tracked by RecallDetector.

Related Recalls

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