Facility

Handicare USA, Inc.

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

Key facts

4recalls · 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)	3007802293
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	10888 Metro Ct. Maryland Heights, MO, US 63043
Registration status	Active · expires 2026
Parent company	Handicare USA, Inc. (owner-operator 10029966)
Brand names	Handicare Distributed Product

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

Chair, Adjustable, Mechanical
Product code INN (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.3100

Recalls & enforcement

Class IITerminated2017-11-03
Premature strap wear and breakage at maximum weight conditions (625 lbs.).
Class IITerminated2017-09-08
During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 lbs). We have identified the root cause as a supplied component that was not to s…
Class IITerminated2015-03-26
Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
Class IITerminated2014-04-15
During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of…

FDA inspections (1)

NAI2016-01-27
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 Handicare USA, 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. “Handicare USA, Inc. (FEI 3007802293) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007802293-handicare-usa-inc/

Not open yet

Alerts for Handicare USA, Inc.

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.