Facility

Sol-Millennium Medical, Inc.

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

Key facts

1recalls · worst Class II

2inspections · worst VAI

1warning letters

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

FDA Establishment Identifier (FEI)	3014312726
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198
Location	311 S Wacker Drive Chicago, IL, US 60606
Registration status	Active · expires 2026
Parent company	Sol-Millennium (owner-operator 10035370)
Brand names	Sol-M Blunt Fill Needle; Sol-M Blunt Fill Needle with 5 micron filter

Activity by year

Recalls (1)
Inspections (2)
Warning letters (1)

Devices registered here (1)

Needle, Aspiration And Injection, Disposable
Product code GAA (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800

Recalls & enforcement

Class IIOngoing2024-05-09
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

FDA inspections (2)

VAI2025-05-08
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2023-12-20
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.

FDA warning letters (1)

Warning Letter2024-03-18
Warning Letter (opens in a new tab) · Chicago Illinois

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Sol-Millennium

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. “Sol-Millennium Medical, Inc. (FEI 3014312726) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014312726-sol-millennium-medical-inc/

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