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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.

Official notice
NIPRO Technical ServicesHealth & Personal CareMedical DevicesCatalog/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

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
December 12, 2025
Status
ACTIVE
Severity
7/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
NIPRO Technical Services
Product type
Conductivity Standard Solution
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
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 12, 2025

  2. Reported by FDA DEVICE

    February 4, 2026

  3. RecallRadar source check

    February 11, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

Conductivity Standard Solutions are used primarily in medical settings for calibrating conductivity meters, crucial for ensuring accurate readings in treatments such as dialysis.

Why This Is Dangerous

The defect in conductivity values can lead to inaccurate measurements, potentially endangering patients if incorrect data is used in treatment decisions.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall may cause inconvenience for healthcare providers and patients who depend on accurate calibration for effective treatment.

Practical Guidance

How to identify if yours is affected

  1. Check the product packaging for model numbers 10001, 10011, 10021, 10032, 10040, 10040c, or 10041.
  2. Verify if your product was purchased recently from a healthcare supplier.
  3. Contact NIPRO Technical Services to confirm if your product is affected.

Where to find product info

Model numbers and lot numbers can typically be found on the product label or packaging.

What timeline to expect

Expect the refund or replacement process to take approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Document all communications with NIPRO Technical Services.
  • Follow up via phone or email if you do not receive a response within a week.

How to prevent similar issues

  • Always verify the calibration standards being used in medical settings.
  • Look for updated recalls or safety notices from manufacturers before use.
  • Consider purchasing calibration solutions from reputable brands with good customer reviews.

Documentation advice

Keep records of your purchase, including receipts, for warranty and refund purposes.

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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.

Key Facts

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

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
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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