CLASS I ONGOING Device recall · Reported 21 May 2025 · FDA Enforcement Report

MedicaLyte Liquid Bicarbonate Concentrate recalled

Nipro Renal Soultions USA is recalling MedicaLyte Liquid Bicarbonate Concentrate, distributed nationwide in the US. The recall was initiated on 11 Apr 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesa. 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.

Quantity recalled816,840 units (BC+201), 39,228 units (BC+100)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1730-2025
FDA event ID: 96646
Recalling firm: Nipro Renal Soultions USA, Lewisberry, PA
Classification: Class I
Status: Ongoing
Recall initiated: 11 Apr 2025
FDA classified: 14 May 2025
Reported: 21 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Hip & Knee Implants

Timeline

11 Apr 2025	Recall initiated by company
14 May 2025	Classified by FDA	+33 days
21 May 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for the presence of visible foreign matter.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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).

Where it was distributed

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.

Nationwide Arizona California Colorado Delaware Florida Georgia Illinois Kansas Louisiana Massachusetts Michigan Minnesota Missouri North Carolina New Jersey Nevada New York Ohio Oklahoma Oregon

Questions about this recall

Why was it recalled?

Potential for the presence of visible foreign matter.

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Nipro Renal Soultions USA

All 6

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS II	MedicaLyte Bicarbonate Powder recalled by Nipro Renal Soultions USA	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS II	Citric Complete Liquid Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS II	MedicaLyte Liquid Bicarbonate Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
15 Jan 2025Device	CLASS II	Citric Complete - Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Labeling Errors	10 states

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12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide