Skip to content

Wescor, Inc.

United StatesFDA applicant, unverified

Devices
13
FDA recalls
5

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Wescor, Inc. makes

Wescor, Inc. manufactures medical devices including colloid osmometers, sweat conductivity analyzers, sweat chloride analyzers, neonatal sweat analysis systems, vapor pressure osmometers, slide stainers, stain packs, stain concentrates, sweat inducers, and perfusometers.

The company's portfolio includes Class I and Class II devices listed in the FDA 510(k) registry. Wescor, Inc. is based in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

Newest first, rows 1-13 of 13

Search and filter all 13 devices
Skip device list

Rows 1-13 of 13

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 5 recalls initiated by Wescor, Inc., the earliest on 2007-12-26 and the most recent on 2010-01-06. By recorded status: 5 terminated. The reasons filed fall into these groups: sterility or contamination and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2010

    • 6 Jan 2010 Z-1027-2010 Unclassified (pre-2012) Terminated Stains used for diagnostic use may be contaminated with bacteria. Distribution: Nationwide, Foreign distribution to Algeria, Australia, Austria, Canada, Cyprus, Denmark, France, Germany, Hungary,…
      Full distribution text Nationwide, Foreign distribution to Algeria, Australia, Austria, Canada, Cyprus, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Kuwait, Malta, Netherlands, Oman, Panama, Poland, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, UK, and Venezuela.
    • 6 Jan 2010 Z-1028-2010 Unclassified (pre-2012) Terminated Stains used for diagnostic use may be contaminated with bacteria. Distribution: Nationwide, Foreign distribution to Algeria, Australia, Austria, Canada, Cyprus, Denmark, France, Germany, Hungary,…
      Full distribution text Nationwide, Foreign distribution to Algeria, Australia, Austria, Canada, Cyprus, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Kuwait, Malta, Netherlands, Oman, Panama, Poland, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, UK, and Venezuela.
    • 6 Jan 2010 Z-1029-2010 Unclassified (pre-2012) Terminated Stains used for diagnostic use may be contaminated with bacteria. Distribution: Nationwide, Foreign distribution to Algeria, Australia, Austria, Canada, Cyprus, Denmark, France, Germany, Hungary,…
      Full distribution text Nationwide, Foreign distribution to Algeria, Australia, Austria, Canada, Cyprus, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Kuwait, Malta, Netherlands, Oman, Panama, Poland, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, UK, and Venezuela.

  • 2007

    • 26 Dec 2007 Z-1350-2008 Unclassified (pre-2012) Terminated Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing. Distribution: Worldwide- USA, Argentina, Australia, Brazil, Canada, Denmark, England, France, Germany, Greece, Hungary, Japan,…
      Full distribution text Worldwide- USA, Argentina, Australia, Brazil, Canada, Denmark, England, France, Germany, Greece, Hungary, Japan, Malaysia, Mexico, The Netherlands, New Zealand, Paraguay, Poland, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and The United Kingdom.
      Submission number: K834208
    • 26 Dec 2007 Z-1351-2008 Unclassified (pre-2012) Terminated Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing. Distribution: Worldwide- USA, Argentina, Australia, Brazil, Canada, Denmark, England, France, Germany, Greece, Hungary, Japan,…
      Full distribution text Worldwide- USA, Argentina, Australia, Brazil, Canada, Denmark, England, France, Germany, Greece, Hungary, Japan, Malaysia, Mexico, The Netherlands, New Zealand, Paraguay, Poland, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and The United Kingdom.
      Submission number: K834208

Frequently asked questions

How many devices does Wescor, Inc. have in the registry?

The registry currently lists 13 devices for Wescor, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Wescor, Inc.'s devices?

Among its 13 most recently registered devices, Wescor, Inc. has devices listed in FDA 510(k) (13 devices).

What risk classes do Wescor, Inc.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Wescor, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Wescor, Inc.?

FDA recall records list 5 recalls initiated by Wescor, Inc., the most recent initiated on 6 Jan 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Wescor, Inc. in the registry?

The most recently registered devices listed for Wescor, Inc. include COLLOID OSMOMETER 4400, STAIN PACK FOR AEROSPRAY SLIDE STAINER, WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER and WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY.

Generated automatically from registry data and not verified by a human reviewer.