Lower risk Medical device recall · FDA · Published April 11, 2025

Nipro Renal Solutions MedicaLyte Liquid Bicarbonate Concentrate Recall: Visible Foreign

Nipro Renal Solutions recalls MedicaLyte Liquid Bicarbonate Concentrate (models BC+201 and BC+100) due to potential visible foreign matter. Affected units include specific lot numbers and packaging.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1730-2025Medical device Nipro Renal Solutions ›

Lower-risk recall

Potential for the presence of visible foreign matter.

Take action

Contact the company

Recalling firmNipro Renal Soultions USA, Corporation509 Fishing Creek Rd · Lewisberry, PA 17339-9517

✎ GovInfoNow plain-language explainer

Nipro Renal Solutions is recalling MedicaLyte Liquid Bicarbonate Concentrate bottles that may contain visible foreign matter. This could pose a risk if the foreign material contaminates the solution before use. Read more at govinfonow.com/recall/52465-nipro-renal-solutions-medicalyte-liquid-bicarbonate-concentrate-recall-visible-foreign.

Source Summary by GovInfoNow · govinfonow.com/recall/52465-nipro-renal-solutions-medicalyte-liquid-bicarbonate-concentrate-recall-visible-foreign · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1730-2025

Cite this page

“Nipro Renal Solutions MedicaLyte Liquid Bicarbonate Concentrate Recall: Visible Foreign.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52465-nipro-renal-solutions-medicalyte-liquid-bicarbonate-concentrate-recall-visible-foreign. Based on FDA recall #Z-1730-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1730-2025%22&limit=1).

The FDA announced on April 11, 2025, that Nipro Renal Solutions USA, Corporation is recalling MedicaLyte Liquid Bicarbonate Concentrate due to the potential for visible foreign matter. Owners should contact the company for a refund.

How to tell if you have it

Brand: Nipro Renal Solutions
Product: MedicaLyte Liquid Bicarbonate Concentrate
Model Numbers: BC+201 (45X), BC+100 36.83X
Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case)
Units affected: 816,840 units of BC+201; 39,228 units of BC+100

The hazard

The recall addresses the potential for the presence of visible foreign matter in the product. The FDA classified this as a Class I recall, indicating a high risk of adverse health consequences.

Context

GovInfoNow's records show Nipro Renal Solutions USA, Corporation has issued two other recalls since November 22, 2024, including an August 5, 2026, recall for high endotoxin risk and a November 22, 2024, recall for mislabeled chemical composition. Other recent recalls of similar products include the July 14, 2026, Fresenius NaturaLyte Liquid Acid Concentrate Recall for blue-green discoloration complaints and the July 6, 2026, Spectra Medical Devices Sodium Chloride Injection Recall for infection risk.

How to tell if you have this one

Check for model numbers BC+201 (45X) or BC+100 36.83X on the bottle. Look for specific lot numbers listed in the recall details. The product comes in plastic bottles packaged in corrugated shipper cases with 4 bottles per case.

Brand
Nipro Renal Solutions
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the model number and lot number on the bottle to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 26 states.

FDA distribution: “US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, IL, KS, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, PR. International distribution to Guatemala and Panama.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington.

Recall timeline

FDA published this recall 40 days after the firm started it.

Apr 11, 2025Firm started the recall
May 14, 2025FDA classified it Class I
May 21, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What lot numbers are affected?

Lot numbers N3C014, N3C018, N3F018, N4C010, N4C012, N4E004, N4L021, N4L022, N4L037, N5A044 are affected.

Similar recalls

Latest medical device recalls

Keep exploring

More Nipro Renal Solutions recalls

Link to this recall

<a href="https://govinfonow.com/recall/52465-nipro-renal-solutions-medicalyte-liquid-bicarbonate-concentrate-recall-visible-foreign">Nipro Renal Solutions MedicaLyte Liquid Bicarbonate Concentrate Recall: Visible Foreign (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1730-2025 (April 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1730-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.