Facility

Mesa Germany GmbH

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

Key facts

3recalls · 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)	3008925937
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	Auf der Lind 10 Waldems Hesse, DE 65529
Registration status	Active · expires 2026
Parent company	MESA LABORATORIES, INC. (owner-operator 1720309)
Brand names	Gke Steri-Record Steam Mini-Bio-Plus Self-Contained Biological Indicator (SCBI)

Activity by year

Recalls (3)

Devices registered here (1)

Indicator, Biological Sterilization Process
Product code FRC (opens in a new tab) · Class II · General Hospital · 21 CFR 880.2800

Recalls & enforcement

Class IITerminated2017-05-12
Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications.
Class IITerminated2016-04-04
Product resistance has fallen outside of label claim within expiry.
Class IITerminated2013-09-13
Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.

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. “Mesa Germany GmbH (FEI 3008925937) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008925937-mesa-germany-gmbh/

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