Facility

VisionAir Solutions

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

Key facts

1recalls · 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)	3010197296
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	1800 Triplett Blvd Akron, OH, US 44306
Registration status	Active · expires 2026
Parent company	Theken Companies, LLC (owner-operator 10050903)
Brand names	VisionAir 3D Stent Architect; VisionAir 3D Stent

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Prosthesis, Tracheal, Preformed/Molded
Product code NWA (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.3720

Recalls & enforcement

Class IIOngoing2025-09-11
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

FDA inspections (2)

VAI2024-03-14
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2017-02-09
No Action Indicated · Compliance: Devices; Postmarket Assurance: 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.

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. “VisionAir Solutions (FEI 3010197296) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010197296-visionair-solutions/

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