Z-0528-2025Class II

smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

Name: Z-0528-2025 smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Creator: Smiths Medical ASD, Inc.
Published: 2024-10-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-10-28 / Open, Classified / root cause: labeling and UDI

FDA source

Smiths Medical ASD, Inc. began a recall of smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP on 2024-10-28. FDA classified it as Class II and gives the reason as "Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0528-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-28
Posted: 2024-11-25
Recalling firm: Abbott Medical
Product: smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Product code: BSR Stylet, Tracheal Tube
Reason for recall: Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Smiths Medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 10/28/2024, mailed using a traceable means. The notice explained the issue, potential risk, and requested the consignee locate and destroy all affected products, and distribute the notice to all affected parties. Distributors were directed to notify their customers. For questions: About the communication: [email protected], 1-800-913-3897; To report adverse events: [email protected], 1-866-216-8806
Quantity in commerce: 10,223 units
Distribution: Worldwide distribution.
Product codes and lots: REF 14-504-68, UDI/DI 35021239002586, Lot Numbers: 0003393, 0003394, 0003357, 0003358, 0003267, 0003368, 0003634, 0003254, 0003369, 0003165, 0003184, 0003196, 0003204, 0003206, 0003226, 0003256, 0003300, 0003307, 0003308, 0003314, 0003322, 0003359, 0003360, 0003361, 0003362, 0003363, 0003364, 0003377, 0003380, 0003635, 0003643; REF 14-504-68JP, UDI/DI 35021239002586, Lot Numbers: 0003369, 0003377, 0003393, 0003394, 0003634, 0003635, 0003643

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0528-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0527-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0528-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0529-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25

Product code BSR

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)