Facility

WATERS MEDICAL SYSTEMS, LLC

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst NAI

—warning letters in our data

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

FDA Establishment Identifier (FEI)	2123774
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	2900 37th St NW ROCHESTER, MN, US 55901
Registration status	Active · expires 2026
Parent company	Waters Medical Systems LLC (owner-operator 10024390)
Brand names	RM4 Kidney Perfusion System

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

System, Perfusion, Kidney
Product code KDN (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5880

Recalls & enforcement

Class IITerminated2022-03-21
There is a potential for the WCM cassette pump head leaking solution.

FDA inspections (2)

NAI2024-08-14
No Action Indicated · Compliance: Devices
NAI2017-04-20
No Action Indicated · Compliance: Devices

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.

All facilities operated by Waters Medical Systems LLC

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. “WATERS MEDICAL SYSTEMS, LLC (FEI 2123774) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2123774-waters-medical-systems-llc/

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