Facility

MEDSPIRA LLC

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

Key facts

1recalls · worst Class II

3inspections · worst VAI

—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)	3008414621
Establishment type	Manufacture Medical Device
Location	2718 Summer St NE Minneapolis, MN, US 55413
Registration status	Active · expires 2026
Parent company	MEDSPIRA LLC (owner-operator 10030584)
Brand names	mcompass Biofeedback Anorectal Manometry System.

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (2)

Device, Biofeedback
Product code HCC (opens in a new tab) · Class II · Neurology · 21 CFR 882.5050
Monitor, Esophageal Motility, Anorectal Motility, And Tube
Product code KLA (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1725

Recalls & enforcement

Class IITerminated2017-06-14
Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.

FDA inspections (3)

NAI2025-06-27
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2024-01-16
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-09-06
No Action Indicated · Compliance: Devices; Postmarket Assurance: 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.

All facilities operated by MEDSPIRA 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. “MEDSPIRA LLC (FEI 3008414621) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008414621-medspira-llc/

Not open yet

Alerts for MEDSPIRA LLC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.