Facility

SPECTRA MEDICAL DEVICES, LLC

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

Key facts

1recalls · worst Class I

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)	3000204727
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	299 Ballardvale St Ste 1 WILMINGTON, MA, US 01887
Registration status	Active · expires 2026
Parent company	SPECTRA MEDICAL DEVICES, LLC (owner-operator 9012618)
Brand names	Disposable Epidural Anesthesia Tray

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Anesthesia Conduction Kit
Product code CAZ (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5140

Recalls & enforcement

Class IOngoing2026-07-06
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, …

FDA inspections (2)

VAI2024-04-25
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2017-03-30
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 SPECTRA MEDICAL DEVICES, 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. “SPECTRA MEDICAL DEVICES, LLC (FEI 3000204727) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000204727-spectra-medical-devices-llc/

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