Z-2401-2021Class II

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

Name: Z-2401-2021 smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile
Creator: Smiths Medical ASD Inc.
Published: 2021-08-04
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-08-04 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile on 2021-08-04. FDA classified it as Class II and gives the reason as "The incorrect device is contained in the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2401-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-04
Posted: 2021-09-01
Terminated: 2025-03-11
Recalling firm: Abbott Medical
Product: smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Product code: OGK Orotracheal Intubation Guide Kit
Reason for recall: The incorrect device is contained in the package.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The letter dated 8/4/2021 was issued 8/4/2021 via tracked mail and requested return of the product.
Quantity in commerce: 1,590 units
Distribution: International distribution was made to the countries of Canada, Japan, Indonesia, and Spain.
Product codes and lots: Lot 4015424

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2401-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2401-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-01

Product code OGK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)