HIGH

NIPRO Technical Services Recalls Conductivity Solutions Over Calibration Risk

NIPRO Technical Services recalled 499 units of Conductivity Standard Solutions on December 12, 2025. A defect affects the conductivity values, leading to incorrect readings for dialysate. Patients and healthcare providers must stop using the product immediately.

Quick Facts at a Glance

Recall Date
December 12, 2025
Hazard Level
HIGH
Brand
NIPRO Technical Services
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact NIPRO Technical Services, Inc. or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled products include Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041. These solutions calibrated conductivity meters and were distributed nationwide across multiple states.

The Hazard

The defect in the conductivity values can lead to incorrect readings, which pose a significant risk for patients relying on accurate measurements for dialysate. This discrepancy can affect treatment decisions.

Reported Incidents

No specific injuries or incidents have been reported. The recall falls under Class II, indicating a potential risk of harm.

What to Do

Stop using the Conductivity Standard Solutions immediately. Follow the manufacturer's recall instructions and contact NIPRO Technical Services or your healthcare provider for further guidance.

Contact Information

For more information, contact NIPRO Technical Services at their official website or through the link provided in the FDA notice.

Key Facts

  • 499 units recalled
  • Defect affects calibration accuracy
  • Nationwide distribution across several states
  • Product sold under NIPRO Technical Services

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Catalog/Model Numbers/ Lot Numbers / UDI codes: 10001 14250616-1019106 (01) 0 0850016 97600 0 (17) 251030 (10) SHOWCASE 10011 14250616-1019107 (01) 0 0850016 97609 3 (17) 251030 (10) SHOWCASE 10040c 50250624-1019120 (01) 0 0850016 97636 9 (17) 251030 (10) SHOWCASE 10040 50250624-1019119 (01) 0 0850016 97635 2 (17) 251030 (10) SHOWCASE 10032 14250616-1019108 (01) 0 0850016 97631 1 (17) 251030 (10) SHOWCASE 10041 50250522-1018643 (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10041 50250624-1019121 (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10021 15F250603-1018834 (01) 0 0850016 97619 2 (17) 251030 (10) SHOWCASE
Affected States
ALL
Report Date
February 4, 2026
Recall Status
ACTIVE

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