Facility

Mesa Laboratories Bozeman Manufacturing Facility (Zoot)

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

Key facts

3recalls · 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)	3013667284
Establishment type	Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility
Location	625 Zoot Way Bozeman, MT, US 59718
Registration status	Active · expires 2026
Parent company	MESA LABORATORIES, INC. (owner-operator 1720309)
Brand names	Mesa ProChem B-D 121 Bowie-Dick Test Pack; Mesa ProChem B-D Test Pack

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (1)

Indicator, Physical/Chemical Sterilization Process
Product code JOJ (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.

FDA inspections (2)

NAI2019-06-14
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-12-07
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.

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 Laboratories Bozeman Manufacturing Facility (Zoot) (FEI 3013667284) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013667284-mesa-laboratories-bozeman-manufacturing-/

Not open yet

Alerts for Mesa Laboratories Bozeman Manufacturing Facility (Zoot)

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.