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Miltex, Inc.

United StatesFDA applicant, unverified

Devices
23
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Miltex, Inc. makes

Miltex, Inc. manufactures reusable rigid sterilization containers and related accessories, including membrane tack kits for securing instruments. Their portfolio also includes a range of dental instruments, such as cutting tools, files, probes, excavators, pluggers, plastic instruments, scalers, and carvers, designed for clinical use. Additionally, they produce surgical cassettes and Thompson cassettes for organized instrument storage and processing.

The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as either Class I or Class II. These instruments and containers are listed in the FDA’s 510(k) clearance registry. Miltex, Inc. is based in the United States.

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

Catalogue23

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Rows 1-23 of 23

FDA recalls2

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

FDA recall records list 2 recalls initiated by Miltex, Inc., the earliest on 2007-04-09 and the most recent on 2008-11-17. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. 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.

  • 2008

    • 17 Nov 2008 Z-0862-2009 Unclassified (pre-2012) Terminated Blade may break: Over milling of the blade resulted in tip more narrow than specified. Distribution: Nationwide Distribution and Canada.

  • 2007

    • 9 Apr 2007 Z-0767-2007 Unclassified (pre-2012) Terminated Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex) Distribution: Nationwide to distributors in CA, FL, IA, ID, NM, NJ, OH, PA, RI, and VA.

Frequently asked questions

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

The registry currently lists 23 devices for Miltex, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Miltex, Inc.'s devices?

Among its 23 most recently registered devices, Miltex, Inc. has devices listed in FDA 510(k) (23 devices).

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

Among its 23 most recently registered devices, the classes recorded for Miltex, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Miltex, Inc.?

FDA recall records list 2 recalls initiated by Miltex, Inc., the most recent initiated on 17 Nov 2008. 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 Miltex, Inc. in the registry?

The most recently registered devices listed for Miltex, Inc. include MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS), MILTEX MEMBRANE TACK KIT, DENTAL INSTRUMENTS - CUTTING INSTRUMENT and DENTAL INSTRUMENTS - FILES.

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