Z-0146-2025Class II

smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000

Name: Z-0146-2025 smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Creator: Smiths Medical ASD Inc.
Published: 2024-07-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-07-18 / Open, Classified / root cause: packaging

FDA source

Smiths Medical ASD Inc. began a recall of smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000 on 2024-07-18. FDA classified it as Class II and gives the reason as "Uncertainty in the seal integrity of the sterile packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0146-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-18
Posted: 2024-10-23
Recalling firm: Abbott Medical
Product: smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Product code: BYD Condenser, Heat And Moisture (Artificial Nose)
Reason for recall: Uncertainty in the seal integrity of the sterile packaging.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Smiths medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 07/18/2024 via traceable mailing. The notice explained the issue with the products, potential risk and requested the affected devices be destroyed. Distributors were directed to notify their customers by forwarding the notice. Questions - contact [email protected].
Quantity in commerce: 27,971 units
Distribution: Worldwide distribution.
Product codes and lots: UDI/DI 35019315022405, Lot Numbers: 4122013, 4130776, 4130777

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0146-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0143-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0144-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0145-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0146-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0147-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23

Product code BYD

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)