The Recall Desk
HighFDA (Devices)·Z-2401-2021·Announced 2021-09-08

Smiths Medical Tracheal Intubation Stylet Recall Due to Incorrect Device

Smiths Medical ASD Inc. is recalling 1,590 units of Smiths Medical Portex Tracheal Intubation Stylets because incorrect devices were found in packages. The affected lot was distributed internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The incorrect device in the package presents a potential risk to patient safety in tracheal intubation procedures, but no incidents have been reported. Per the rubric, risk-of-harm products without reported injury score 3 (High).

Plain-English summary

Smiths Medical ASD Inc. is recalling 1,590 units of the Smiths Medical Portex Tracheal Intubation Stylet, model REF 100/120/200 (4.0mm OD X 335mm), sterile, lot 4015424.

The recall was initiated because the incorrect device was contained in some packages.

The affected product was distributed internationally to Canada, Japan, Indonesia, and Spain.

Consumers and healthcare providers who have received this product should verify the device matches the specifications on the package. If an incorrect device was received, contact Smiths Medical ASD Inc. for instructions on return and replacement.

The recalled product

Product
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Tracheal Intubation
Hazard
  • device-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 4015424

Distribution

Distribution scope not specified by the agency.

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