CLASS II ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report

smiths medical portex, 'Orator' Speaking Valve For Tracheostomy Tube recalled

Smiths Medical ASD is recalling smiths medical portex, 'Orator' Speaking Valve For Tracheostomy Tube. The recall was initiated on 18 Jul 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 35019315022405, Lot Numbers: 4122013, 4130776, 4130777

Quantity recalled27,971 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0146-2025
FDA event ID: 95181
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 18 Jul 2024
FDA classified: 23 Oct 2024
Reported: 30 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

18 Jul 2024	Recall initiated by company
23 Oct 2024	Classified by FDA	+97 days
30 Oct 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Uncertainty in the seal integrity of the sterile packaging.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution.

Questions about this recall

Is smiths medical portex, 'Orator' Speaking Valve For Tracheostomy Tube recalled?

Yes. Smiths Medical ASD recalled smiths medical portex, 'Orator' Speaking Valve For Tracheostomy Tube on 18 Jul 2024. The recall is Class II and its status is Ongoing. Recall number Z-0146-2025.

Why was it recalled?

Uncertainty in the seal integrity of the sterile packaging.

Which lots are affected?

UDI/DI 35019315022405, Lot Numbers: 4122013, 4130776, 4130777

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Smiths Medical ASD

All 284

Reported	Class	Recall	Company	Reason	Where
14 May 2025Device	CLASS I	Cadd Solis Hspca Pump *Updated 5/27/26* Scope updated recalled	Smiths Medical ASD	Lead & Heavy Metals	Nationwide
14 May 2025Device	CLASS I	Cadd-Solis Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
14 May 2025Device	CLASS I	CADD Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
14 May 2025Device	CLASS I	Cadd-Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Lead & Heavy Metals	Nationwide
14 May 2025Device	CLASS I	Cadd-Solis Hpca Ambulatory Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Lead & Heavy Metals	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide