Facility

TURNCARE, INC.

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

Key facts

2recalls · 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)	3013682457
Establishment type	Manufacture Medical Device
Location	230 West Parkway Pompton Plains, NJ, US 07444
Registration status	Active · expires 2026
Parent company	Turncare, Inc. (owner-operator 10054735)
Brand names	Guardian

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Mattress, Air Flotation, Alternating Pressure
Product code FNM (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5550

Recalls & enforcement

Class IIOngoing2023-11-01
A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
Class IIOngoing2023-08-10
A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.

FDA inspections (2)

VAI2024-12-11
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2023-06-26
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 Turncare, 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. “TURNCARE, INC. (FEI 3013682457) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013682457-turncare-inc/

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