Facility

Coapt LLC

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

Key facts

2recalls · worst Class II

4inspections · 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)	3010605876
Establishment type	Complaint File Establishment per 21 CFR 820.198; Remanufacture Medical Device; Manufacture Medical Device
Location	303 W. Institute Pl. Chicago, IL, US 60610
Registration status	Active · expires 2026
Parent company	Coapt, LLC (owner-operator 10045459)
Brand names	Coapt Evaluation Kit

Activity by year

Recalls (2)
Inspections (4)
Warning letters (1)

Devices registered here (1)

Device, Prosthesis Alignment
Product code IQO (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.3025

Recalls & enforcement

Class IIOngoing2023-10-02
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Class IIOngoing2023-10-02
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

FDA inspections (4)

NAI2024-10-28
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2022-11-02
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2019-12-11
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2016-09-20
No Action Indicated · Compliance: Devices

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 Letter2016-01-08
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 Coapt, 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. “Coapt LLC (FEI 3010605876) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010605876-coapt-llc/

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