Z-2466-2023Class II

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

Name: Z-2466-2023 PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Creator: Smiths Medical ASD Inc.
Published: 2023-07-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-07-18 / Open, Classified / root cause: design

FDA source

Smiths Medical ASD Inc. began a recall of PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter on 2023-07-18. FDA classified it as Class II and gives the reason as "Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2466-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-18
Posted: 2023-08-28
Recalling firm: Abbott Medical
Product: PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Product code: CAH Filter, Bacterial, Breathing-Circuit
Reason for recall: Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
Root cause tag: design
FDA root cause: Device Design
Action: Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 07/18/2023 by U.S. Mail. The notice explained the problem, potential risk, and requested the consignees perform the following actions: 1. Discontinue use and distribution of affected product; quarantine all product 2. Inform all users within your facility 3. If the product was further distributed, please indicate the contact information for the new owner of the product on the response form. Smiths Medical is seeking the return of the affected product.
Quantity in commerce: 66,633 units
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2466-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2466-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-28

Product code CAH

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)