FDA Medical devices recall ·
MedicaLyte Liquid Bicarbonate Concentrate recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1730-2025
- Date
- (initiated April 11, 2025)
- Company / brand
- Nipro Renal Soultions USA, Corporation
509 Fishing Creek Rd, Lewisberry, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 816,840 units (BC+201), 39,228 units (BC+100)
- Hazard tags
- Foreign material
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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).
Why was it recalled?
Potential for the presence of visible foreign matter.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
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: Arizona California Colorado Delaware Florida Georgia Illinois Kansas Louisiana Massachusetts Michigan Minnesota Missouri North Carolina New Jersey Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina Texas Utah Virginia Washington
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1730-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.