Class II U.S. Food and Drug Administration

NIPRO Technical Services, Inc. Conductivity Standard Solution Catalog/Model Numbers recall: due to a defect associated with the conductivity values of the solution used

Recall published 9 months ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1185-2026
Published
February 4, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
NIPRO Technical Services, Inc.
Product type
Medical devices
Units affected
499 units
Distribution
Nationwide
Made in
United States
Lot / code info
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

Products covered by this recall

Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • 10001
  • 10011
  • 10021
  • 10032
  • 10040
  • 10040c
  • 1004

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

NIPRO Technical Services, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: NIPRO Technical Services, Inc. — 3110 N Oakland Ste 101, Mesa, AZ, 85215-1168

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was NIPRO Technical Services, Inc. medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number 10001, 10011, 10021. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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