Lower risk Medical device recall · FDA · Published August 4, 2021

Smiths Medical Tracheal Intubation Stylet Recall: Incorrect Device in Package

Smiths Medical recalls sterile tracheal intubation stylets with incorrect device in package. Consumers should check product details and contact Smiths Medical for guidance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2401-2021Medical device Smiths Medical ›

Lower-risk recall

The incorrect device is contained in the package.

Take action

Contact the company

Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690

✎ GovInfoNow plain-language explainer

Smiths Medical is recalling sterile tracheal intubation stylets that contain an incorrect device. This recall is due to the risk of using the wrong device, which could lead to improper medical procedures. Read more at govinfonow.com/recall/62086-smiths-medical-tracheal-intubation-stylet-recall-incorrect-device-in-package.

Source Summary by GovInfoNow · govinfonow.com/recall/62086-smiths-medical-tracheal-intubation-stylet-recall-incorrect-device-in-package · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2401-2021

Cite this page

“Smiths Medical Tracheal Intubation Stylet Recall: Incorrect Device in Package.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/62086-smiths-medical-tracheal-intubation-stylet-recall-incorrect-device-in-package. Based on FDA recall #Z-2401-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2401-2021%22&limit=1).

Smiths Medical ASD Inc. recalled Smiths Medical Portex Tracheal Intubation Stylet units due to incorrect device packaging, according to the FDA on August 4, 2021.

How to tell if you have it

Brand: Smiths Medical
Product: smiths medical portex Tracheal Intubation Stylet
REF: 100/120/200
Size: 4.0mm OD X 335mm
Lot: 4015424

The hazard

The hazard is that the incorrect device is contained in the package.

Context

GovInfoNow's records show Smiths Medical ASD, Inc. has 73 other recalls on record since June 5, 2017. Other recent recalls of similar products include Covidien Shiley Tracheostomy Tube Recall (April 15, 2026), Medline Intubation Tray Recall (December 24, 2025), and Medline Convenience Kits Recall (January 7, 2026).

How to tell if you have this one

Check for the product name 'Smiths Medical portex Tracheal Intubation Stylet', reference numbers 100/120/200, and dimensions 4.0mm OD X 335mm. The product is sold in boxes of 10, sterile, and lot number 4015424.

Brand
Smiths Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name, reference numbers, dimensions, and lot number to confirm if the item is recalled.

How this recall unfolded

Recall timeline

FDA terminated this recall 3.6 years after the firm started it.

Aug 4, 2021Firm started the recall
Sep 1, 2021FDA classified it Class II
Sep 8, 2021Published in FDA’s Enforcement Report
Mar 11, 2025FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Smiths Medical recalls

Latest medical device recalls

Keep exploring

More Smiths Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/62086-smiths-medical-tracheal-intubation-stylet-recall-incorrect-device-in-package">Smiths Medical Tracheal Intubation Stylet Recall: Incorrect Device in Package (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2401-2021 (August 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2401-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.