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
Boston Scientific Recalls LGX Preconnect Pump Over Hazardous Performance Issues
Boston Scientific recalled the LGX Preconnect with TENACIO Pump on September 11, 2025. The recall affects devices sold in the U.S. and Canada due to inflation and deflation performance issues. Consumers should stop using the device immediately and follow provided instructions.
Quick Facts at a Glance
- Recall Date
- September 11, 2025
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
Hazard Information
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
Product Details
The recalled products include LGX Preconnect with TENACIO Pump, UPNs: 72404405 (12CM IP) and 72404407 (18CM IP). These devices have UDI-DI numbers 00191506021252 and 00191506021276. The devices were distributed worldwide, including the U.S. and Canada.
The Hazard
The devices may experience inflation and deflation performance issues, which can pose significant health risks. This recall is classified as Class II, indicating a high hazard level.
Reported Incidents
No specific incidents have been reported, but the potential for complications exists. The recall addresses safety concerns related to device performance.
What to Do
Patients and healthcare providers should stop using the device immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.
Contact Information
For more information, visit Boston Scientific's recall page or call their customer service. More details are available at the FDA's enforcement report.
Key Facts
- Recalled product: LGX Preconnect with TENACIO Pump
- Hazard: Inflation and deflation issues
- Recall date: September 11, 2025
- Affected countries: US and Canada
- Contact Boston Scientific for further instructions
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Safety Assessment
Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeInflation and Deflation Device
Sold At
Multiple Retailers
Product Details
Brand
Categories
Model Numbers
1. UPN: 72404405 (12CM IP)
UDI-DI: 00191506021252
Lot numbers: 1100687060
1100687061
2. UPN: 72404407 (18CM IP)
+3 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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