Facility

MUELLER SPORTS MEDICINE, INC.

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

Key facts

1recalls · worst Class II

1inspections · worst NAI

—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)	2110420
Establishment type	Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	ONE QUENCH DR. PRAIRIE DU SAC, WI, US 53578
Registration status	Active · expires 2026
Parent company	MUELLER SPORTS MEDICINE, INC. (owner-operator 2110420)
Brand names	Mueller Aircast Ankle Brace Right White; Mueller Aircast Ankle Brace Left White

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Splint, Extremity, Inflatable, External
Product code FZF (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.3900

Recalls & enforcement

Class IITerminated2020-06-18
Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".

FDA inspections (1)

NAI2025-04-03
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.

All facilities operated by MUELLER SPORTS MEDICINE, 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. “MUELLER SPORTS MEDICINE, INC. (FEI 2110420) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2110420-mueller-sports-medicine-inc/

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