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Sims Portex, Inc.

Also registered as Sims Portex, Ltd.

Country not established

Devices
16
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Sims Portex, Inc. makes

Sims Portex, Inc. manufactures medical devices for anesthesia, respiratory support, and patient safety, including spinal and epidural anesthesia systems, catheters, and needles with integrated needle protection. Their portfolio also covers continuous positive airway pressure (CPAP) systems, breathing filters for anesthesia circuits, and manual resuscitators for adult, pediatric, and infant use. Percutaneous tracheostomy kits with disposable inner cannulas are also part of their offerings.

The company’s devices fall under FDA Class II regulation and are listed via 510(k) clearance in the United States. Sims Portex, Inc. is based in the US.

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

Catalogue16

Newest first, rows 1-16 of 16

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Rows 1-16 of 16

FDA recalls3

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

FDA recall records list 3 recalls initiated by Sims Portex, Inc., initiated on 2002-11-15. By recorded status: 3 terminated. The reasons filed fall into these groups: other reasons as filed. 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.

  • 2002

    • 15 Nov 2002 Z-0808-03 Unclassified (pre-2012) Terminated Peep valve set at the highest level and could result in patient injury Distribution: Nationwide. AL, CA, CO, IA, IL, FL, GA, LA, KS, KY, MA, ME, MN, MO, MS, NC,NM, NY, OK, SC, TN, TX, WA WY, UT, VA Submission number: K014115
    • 15 Nov 2002 Z-0809-03 Unclassified (pre-2012) Terminated Peep valve set at the highest level and could result in patient injury Distribution: Nationwide. AL, CA, CO, IA, IL, FL, GA, LA, KS, KY, MA, ME, MN, MO, MS, NC,NM, NY, OK, SC, TN, TX, WA WY, UT, VA Submission number: K014115
    • 15 Nov 2002 Z-0810-03 Unclassified (pre-2012) Terminated Peep valve set at the highest level and could result in patient injury Distribution: Nationwide. AL, CA, CO, IA, IL, FL, GA, LA, KS, KY, MA, ME, MN, MO, MS, NC,NM, NY, OK, SC, TN, TX, WA WY, UT, VA Submission number: K014115

Frequently asked questions

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

The registry currently lists 16 devices for Sims Portex, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sims Portex, Inc.'s devices?

Among its 16 most recently registered devices, Sims Portex, Inc. has devices listed in FDA 510(k) (16 devices).

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

Among its 16 most recently registered devices, the classes recorded for Sims Portex, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sims Portex, Inc.?

FDA recall records list 3 recalls initiated by Sims Portex, Inc., the most recent initiated on 15 Nov 2002. 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 Sims Portex, Inc. in the registry?

The most recently registered devices listed for Sims Portex, Inc. include CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK, WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733, SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 and SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES.

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