CLASS II ONGOING Device recall · Reported 6 Sep 2023 · FDA Enforcement Report

Portex 0.5u Hydrophobic Disc Filter recalled by Smiths Medical ASD

Smiths Medical ASD is recalling Portex 0.5u Hydrophobic Disc Filter, distributed nationwide in the US. The recall was initiated on 18 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 30351688410645, Lot Numbers: 3419998, 3420441, 3429265, 3432722, 3440006, 3467682, 3467683, 3475349, 3489248, 3493797, 3509569, 3521742, 3526245, 3526337, 3529553, 3529672, 3533982, 3542040, 3546408, 3564993, 3570687, 3570840, 3576129, 3576138, 3635067, 3646546, 3658725, 3678314, 3688406, 3695958, 3696009, 3708884, 3727517, 3728938, 3745100, 3754085, 3764388, 3768464, 3784917, 3788804, 3791099, 3798345, 3802616, 3806235, 3843436, 3846795, 3855864, 3855865, 3858487, 3862085, 3864846, 3867640, 3867641, 3874801, 3878332, 3881026, 3884523, 3891892, 3904937, 3917655

Quantity recalled66,633 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-2466-2023
FDA event ID: 92614
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 18 Jul 2023
FDA classified: 28 Aug 2023
Reported: 6 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

18 Jul 2023	Recall initiated by company
28 Aug 2023	Classified by FDA	+41 days
6 Sep 2023	Published in enforcement report	+9 days

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

Reason for recall

Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product

Product as listed by the FDA

PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product

Which lots are affected?

UDI/DI 30351688410645, Lot Numbers: 3419998, 3420441, 3429265, 3432722, 3440006, 3467682, 3467683, 3475349, 3489248, 3493797, 3509569, 3521742, 3526245, 3526337, 3529553, 3529672, 3533982, 3542040, 3546408, 3564993, 3570687, 3570840, 3576129, 3576138, 3635067, 3646546, 3658725, 3678314, 3688406, 3695958, 3696009, 3708884, 3727517, 3728938, 3745100, 3754085, 3764388, 3768464, 3784917, 3788804, 3791099, 3798345, 3802616, 3806235, 3843436, 3846795, 3855864, 3855865, 3858487, 3862085, 3864846, 3867640, 3867641, 3874801, 3878332, 3881026, 3884523, 3891892, 3904937, 3917655

Where was it sold?

US Nationwide 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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