Facility

SAGE PRODUCTS LLC

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)	1419181
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	3909 3 Oaks Rd CARY, IL, US 60013
Registration status	Active · expires 2026
Parent company	SAGE PRODUCTS LLC (owner-operator 9914017)
Brand names	Prevalon Seated Positioning Cushion with Fastener Strips; Prevalon Seated Positioning System (SPS)

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Mattress, Flotation Therapy, Non-Powered
Product code IKY (opens in a new tab) · Class I · General Hospital · 21 CFR 880.5150

Recalls & enforcement

Class IIOngoing2023-10-23
A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label
Class IITerminated2018-12-05
A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes.

FDA inspections (2)

NAI2024-02-15
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2016-09-01
Voluntary Action Indicated · Compliance: 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.

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. “SAGE PRODUCTS LLC (FEI 1419181) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1419181-sage-products-llc/

Not open yet

Alerts for SAGE PRODUCTS LLC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.