Facility

Bayer Medical Care B.V.

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3012469182
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	Avenue Ceramique 27 Maastricht Limburg, NL 6221 KV
Registration status	Active · expires 2026
Parent company	Bayer AG (owner-operator 10094587)
Brand names	Ball Joint Guide Array (BJGA)

Activity by year

Recalls (1)

Devices registered here (1)

Neurological Stereotaxic Instrument
Product code HAW (opens in a new tab) · Class II · Neurology · 21 CFR 882.4560

Recalls & enforcement

Class IITerminated2014-04-03
There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008.

All facilities operated by Bayer AG

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. “Bayer Medical Care B.V. (FEI 3012469182) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012469182-bayer-medical-care-b-v/

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