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Portex, Ltd.

Also registered as Portex, Inc.

Country not established

Devices
27
FDA recalls
12

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Portex, Ltd. makes

Portex, Ltd. manufactures tracheostomy tubes including cuffed and uncuffed models with reusable inner cannulas, reinforced tracheal tubes, and percutaneous dilation tracheostomy kits with dilators and introducers for specific tube sizes. The company also produces breathing filters such as thermovent HEPA HME filters with CO2 ports, as well as oocyte retrieval sets and embryo replacement and transfer catheters used in reproductive medicine.

All listed devices are classified as Class II medical devices and are registered in the FDA 510(k) database. Portex, Ltd. is based in the United States.

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

Catalogue27

Newest first, rows 1-27 of 27

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Rows 1-27 of 27

FDA recalls12

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 12 recalls initiated by Portex, Ltd., the earliest on 2003-02-20 and the most recent on 2003-10-10. By recorded status: 12 terminated. The reasons filed fall into these groups: labeling or instructions for use and sterility or contamination. 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.

Showing the 10 most recent of 12 recalls.

  • 2003

    • 10 Oct 2003 Z-0166-04 Unclassified (pre-2012) Terminated Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle. Submission number: K965017
    • 18 Jun 2003 Z-1039-03 Unclassified (pre-2012) Terminated Mislabeled:Tracheostomy tube was not fenestrated as specified on the label Distribution: CA, GA, KA, MO Submission number: K922749
    • 16 May 2003 Z-0991-03 Unclassified (pre-2012) Terminated Tracheal tubes may be non-sterile Distribution: Nationwide
    • 16 May 2003 Z-0992-03 Unclassified (pre-2012) Terminated Tracheal tubes may be non-sterile Distribution: Nationwide
    • 16 May 2003 Z-0993-03 Unclassified (pre-2012) Terminated Tracheal tubes may be non-sterile Distribution: Nationwide
    • 16 May 2003 Z-0994-03 Unclassified (pre-2012) Terminated Tracheal tubes may be non-sterile Distribution: Nationwide
    • 16 May 2003 Z-0995-03 Unclassified (pre-2012) Terminated Tracheal tubes may be non-sterile Distribution: Nationwide
    • 16 May 2003 Z-0996-03 Unclassified (pre-2012) Terminated Tracheal tubes may be non-sterile Distribution: Nationwide
    • 16 May 2003 Z-0997-03 Unclassified (pre-2012) Terminated Tracheal tubes may be non-sterile Distribution: Nationwide
    • 16 May 2003 Z-0998-03 Unclassified (pre-2012) Terminated Tracheal tubes may be non-sterile Distribution: Nationwide
Show all 12 recalls

  • 2003

    • 16 May 2003 Z-0999-03 Unclassified (pre-2012) Terminated Tracheal tubes may be non-sterile Distribution: Nationwide
    • 20 Feb 2003 Z-0927-03 Unclassified (pre-2012) Terminated May have incorrectly printed graduation markings along the tube shaft. Distribution: Nationwide, England and France Submission numbers: K894613, K894614, K922665

Frequently asked questions

How many devices does Portex, Ltd. have in the registry?

The registry currently lists 27 devices for Portex, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Portex, Ltd.'s devices?

Among its 27 most recently registered devices, Portex, Ltd. has devices listed in FDA 510(k) (27 devices).

What risk classes do Portex, Ltd.'s devices fall under?

Among its 27 most recently registered devices, the classes recorded for Portex, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Portex, Ltd.?

FDA recall records list 12 recalls initiated by Portex, Ltd., the most recent initiated on 10 Oct 2003. 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 Portex, Ltd. in the registry?

The most recently registered devices listed for Portex, Ltd. include TROCAR CATHETER/THORACIC CATHETER, THERMOVENT 600, 1200, T, 02, BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE and JET VENTILATION ADAPTOR.

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