HIGH
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect
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
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.
Reported Incidents
No specific incidents or injuries have been reported related to this recall. However, the potential for infection poses a serious health risk.
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
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Safety Assessment
Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeSurgical Instruments
Sold At
Multiple Retailers
Product Details
Brand
Categories
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
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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