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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Hazard
- Affected units
- 1,590
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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