---
title: "MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 — FDA record Z-3133-2026 | Is It on Recall"
description: "Hemodialysis concentrates contain high endotoxin levels"
url: https://isitonrecall.com/recall/fda-device-z-3133-2026-medicalyte-liquid-bicarbonate-concentrate-ref-bc-100-and-bc-201/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 — FDA record Z-3133-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 5, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
- **Reason**: Hemodialysis concentrates contain high endotoxin levels
- **Classification**: Class II
- **Recalling firm**: Nipro Renal Soultions USA, Corporation
- **Quantity**: 3,286 cases
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-3133-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3133-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026) |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

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## Dates in the source

- **Report date**: Sep 16, 2026
- **Recall initiation date**: Aug 5, 2026
- **Center classification date**: Sep 10, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3133-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Nipro Renal Soultions USA, Corporation records](https://isitonrecall.com/brand/nipro-renal-soultions-usa-corporation/)