CLASS II Device recall · Reported 8 Sep 2021 · FDA Enforcement Report

smiths medical portex Tracheal Intubation Stylet recalled

Smiths Medical ASD is recalling smiths medical portex Tracheal Intubation Stylet. The recall was initiated on 4 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 4015424

Quantity recalled1,590 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2401-2021
FDA event ID: 88425
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 4 Aug 2021
FDA classified: 1 Sep 2021
Reported: 8 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

4 Aug 2021	Recall initiated by company
1 Sep 2021	Classified by FDA	+28 days
8 Sep 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The incorrect device is contained in the package.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.

Where it was distributed

International distribution was made to the countries of Canada, Japan, Indonesia, and Spain.

Questions about this recall

Why was it recalled?

The incorrect device is contained in the package.

Which lots are affected?

Lot 4015424

Where was it sold?

International distribution was made to the countries of Canada, Japan, Indonesia, and Spain.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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