Facility

Nipro Renal Solutions USA, Corporation

3 recall(s) on record — most severe on record: Class I.

Key facts

3recalls · worst Class I

3inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000142899
Establishment type	Manufacture Medical Device
Location	509 Fishing Creek Rd LEWISBERRY, PA, US 17339
Registration status	Active · expires 2026
Parent company	Nipro Renal Solutions USA, Corp (owner-operator 10035998)
Brand names	MedicaPure

Activity by year

Recalls (3)
Inspections (3)
Warning letters (1)

Devices registered here (1)

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Product code KPO (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5820

Recalls & enforcement

Class IIOngoing2026-08-05
Hemodialysis concentrates contain high endotoxin levels
Class IOngoing2025-04-11
Potential for the presence of visible foreign matter.
Class IIOngoing2024-11-22
The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.

FDA inspections (3)

OAI2026-03-27
Official Action Indicated · Compliance: Devices · citations posted
NAI2019-11-12
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2016-01-21
Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2026-07-16
Warning Letter (opens in a new tab) · Lewisberry Pennsylvania

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Nipro Renal Solutions USA, Corp

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Nipro Renal Solutions USA, Corporation (FEI 1000142899) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000142899-nipro-renal-solutions-usa-corporation/

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