Facility

BSN MEDICAL, INC.

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

Key facts

1recalls · worst Class II

3inspections · 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)	1038963
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	5825 CARNEGIE BLVD. CHARLOTTE, NC, US 28209
Registration status	Active · expires 2026
Parent company	BSN medical GmbH (owner-operator 9047426)
Brand names	Actimove Professional Line Lumbar Sacral Support; Actimove Professional Line Lumbar Sacral Support Comfort Additional Support Belt; Actimove Professional Line Lumbar Sacral Support Comfort Additional Support Belt, Pressure Pad; Actimove Everyday Supports Lumbar Sacral Support; Actimove Professional Line Deluxe Lumbar Sacral Support Rigid Panel, for Women

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Orthosis, Lumbo-Sacral
Product code IPY (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.3490

Recalls & enforcement

Class IITerminated2022-02-01
The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.

FDA inspections (3)

NAI2025-09-05
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2021-03-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2017-11-08
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.

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. “BSN MEDICAL, INC. (FEI 1038963) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1038963-bsn-medical-inc/

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