Facility

NORTHEAST SCIENTIFIC, 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)	3005467144
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	2142 Thomaston Ave Waterbury, CT, US 06704
Registration status	Active · expires 2026
Parent company	NORTHEAST SCIENTIFIC, INC. (owner-operator 9079660)
Brand names	NES IVUS Smart Reprocessed IVUS Catheter

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (2)

Reprocessed Intravascular Ultrasound Catheter
Product code OWQ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1200
Catheter, Ultrasound, Intravascular
Product code OBJ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1200

Recalls & enforcement

Class IIOngoing2025-08-29
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class IITerminated2021-04-26
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.

FDA inspections (2)

NAI2022-07-26
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2018-02-23
Voluntary 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 NORTHEAST SCIENTIFIC, 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. “NORTHEAST SCIENTIFIC, INC. (FEI 3005467144) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005467144-northeast-scientific-inc/

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