HIGH

BioPro Recalls Endo Heads Due to Sterility Risk

BioPro recalled 147 units of Endo Heads on September 9, 2025. A packaging issue may compromise the sterile barrier, leading to infection risk. Healthcare providers and patients should stop using the devices immediately.

Quick Facts at a Glance

Recall Date
September 9, 2025
Hazard Level
HIGH
Brand
BioPro
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact BioPro, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Product Details

The recall involves BioPro Endo Heads with product IDs including 13006, 13012, 13013, and others. These devices were distributed in Texas and Michigan. The devices were sold domestically.

The Hazard

The recall stems from a potential packaging defect that may compromise the sterile barrier of the devices. If the sterility is lost, there is a significant risk of infection during implantation.

What to Do

Patients and healthcare providers must stop using the Endo Heads immediately. Contact BioPro, Inc. or your healthcare provider for further instructions and follow the recall guidelines provided.

Contact Information

For more information, contact BioPro, Inc. directly or visit their official website. Additional details can also be found through the FDA's recall announcement.

Key Facts

  • 147 units recalled
  • Potential infection risk
  • Stop using devices immediately
  • Contact BioPro for instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Brand
Model Numbers
Product ID/UDI-DI 13006 M20913006 13012 M20913012 13013 M20913013 13019 M20913019 13007 M20913007 13008 M20913008 13009 M20913009 13010 M20913010 13011 M20913011 13014 M20913014 13015 M20913015 13016 M20913016 13017 M20913017 13018 M20913018 14823 M20914823 14824 M20914824 14825 M20914825 14826 M20914826 17295 M20917295 17296 M20917296 All lots
all serial numbers
Report Date
October 22, 2025
Recall Status
ACTIVE

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