Facility

NUMED, INC.

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

Key facts

2recalls · worst Class II

2inspections · 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)	1318694
Establishment type	Manufacture Medical Device
Location	2880 MAIN ST. Hopkinton, NY, US 12965
Registration status	Active · expires 2026
Parent company	NUMED, INC. (owner-operator 1318694)
Brand names	BIB CATHETER

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
Product code NVM (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1250

Recalls & enforcement

Class IITerminated2025-04-21
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
Class IITerminated2018-10-17
Instructions for Use booklets were not included on the outer pouch

FDA inspections (2)

NAI2017-04-13
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Project Evaluation: Devices
VAI2016-04-29
Voluntary Action Indicated · Project Evaluation: 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 NUMED, INC.

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. “NUMED, INC. (FEI 1318694) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1318694-numed-inc/

Not open yet

Alerts for NUMED, INC.

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.