Nipro Renal Soultions USA, Corporation: Medical Device Recall in 2025 - (Recall #: Z-1730-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class I

Date Initiated: April 11, 2025

Date Posted: May 21, 2025

Recall Number: Z-1730-2025

Event ID: 96646

Reason for Recall:

Potential for the presence of visible foreign matter.

Status: Ongoing

Product Quantity: 816,840 units (BC+201), 39,228 units (BC+100)

Code Information:

a. Model Number: BC+201 (45X). Case UDI-DI: 10817411022821, Bottle UDI-DI: 00817411022824. All lot numbers. b. Model Number: BC+100 36.83X. Case UDI-DI: 10817411022814, Bottle UDI-DI 00817411022817. Lot Numbers: N3C014, N3C018, N3F018, N4C010, N4C012, N4E004, N4L021, N4L022, N4L037, N5A044.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated