Facility

SOUTHWEST TECHNOLOGIES, INC.

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

Key facts

3recalls · worst Class II

4inspections · 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)	1929833
Establishment type	Manufacture Medical Device
Location	1746 LEVEE RD. North Kansas City, MO, US 64116
Registration status	Active · expires 2026
Parent company	SOUTHWEST TECHNOLOGIES, INC. (owner-operator 1929833)
Brand names	Elasto-Gel Hand Exerciser

Activity by year

Recalls (3)
Inspections (4)

Devices registered here (1)

Exerciser, Non-Measuring
Product code ION (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.5370

Recalls & enforcement

Class IIOngoing2021-05-28
Dose audit failure after sterilization process
Class IITerminated2019-11-18
Elasto-Gel Wound Dressing may be contaminated with mold.
Class IIOngoing2017-12-28
Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts.

FDA inspections (4)

VAI2024-05-16
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2021-12-08
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2019-03-20
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2018-03-05
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.

All facilities operated by SOUTHWEST TECHNOLOGIES, 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. “SOUTHWEST TECHNOLOGIES, INC. (FEI 1929833) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1929833-southwest-technologies-inc/

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