CLASS II ONGOING Device recall · Reported 16 Sep 2026 · FDA Enforcement Report

Citric Complete Liquid Citric Acid Concentrate recalled

Nipro Renal Soultions USA is recalling Citric Complete Liquid Citric Acid Concentrate, distributed nationwide in the US. The recall was initiated on 5 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)

Quantity recalled100 drums/1072 cases

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-3136-2026
FDA event ID: 99573
Recalling firm: Nipro Renal Soultions USA, Lewisberry, PA
Classification: Class II
Status: Ongoing
Recall initiated: 5 Aug 2026
FDA classified: 10 Sep 2026
Reported: 16 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Aug 2026	Recall initiated by company
10 Sep 2026	Classified by FDA	+36 days
16 Sep 2026	Published in enforcement report	+6 days

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

Reason for recall

Hemodialysis concentrates contain high endotoxin levels

Product as listed by the FDA

Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)

Where it was distributed

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.

Nationwide Florida Georgia Illinois Maryland Michigan North Carolina New Jersey Nevada Ohio Pennsylvania

Questions about this recall

Why was it recalled?

Hemodialysis concentrates contain high endotoxin levels

Which lots are affected?

LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)

Where was it sold?

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.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

Other products in this recall event

3 other products · FDA event 99573

This product is part of a recall event; the main page for the event is MedicaLyte Liquid Bicarbonate Concentrate recalled.

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026	CLASS II	MedicaLyte Liquid Bicarbonate Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026	CLASS II	MedicaLyte Bicarbonate Powder recalled by Nipro Renal Soultions USA	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide

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	MedicaLyte Liquid Bicarbonate Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
21 May 2025Device	CLASS I	MedicaLyte Liquid Bicarbonate Concentrate recalled	Nipro Renal Soultions USA	Foreign Material	Nationwide
15 Jan 2025Device	CLASS II	Citric Complete - Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Labeling Errors	10 states

Other Other Medical Devices recalls

All 13,778

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 I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide