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 Femoral Heads Over Sterile Barrier Risk
BioPro recalled 147 femoral heads on September 9, 2025, due to a packaging defect. The defect threatens the sterility of the device, which could lead to infection if implanted. Healthcare providers and patients must stop using these devices immediately.
Quick Facts at a Glance
- Recall Date
- September 9, 2025
- Hazard Level
- HIGH
- Brand
- BioPro
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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 femoral heads with product IDs 14089, 14090, 14091, 14094, 14095, and 14096. These devices were distributed primarily in Texas and Michigan. They were sold in an unspecified price range.
The Hazard
The packaging issue may compromise the sterile barrier of the femoral heads. This defect poses a high risk of infection if the device is implanted.
Reported Incidents
No incidents or injuries have been reported as of the recall date. The risk of infection remains a critical concern.
What to Do
Patients and healthcare providers should cease use of the recalled femoral heads immediately. Contact BioPro, Inc. or your healthcare provider for further instructions.
Contact Information
For questions, contact BioPro, Inc. at their website or through the notification methods provided, including email and telephone.
Key Facts
- 147 femoral heads recalled
- Risk of infection due to compromised sterility
- Distributed in Texas and Michigan
- Immediate halt on usage recommended
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Safety Assessment
Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeFemoral Head Implant
Sold At
Unknown
Product Details
Brand
Categories
Model Numbers
Product ID/UDI-DI 14089 M20914089 14090 M20914090 14091 M20914091 14094 M20914094 14095 M20914095 14096 M20914096 All lots
all serial numbers
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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