smiths medical PORTEX Tracheal Tube Exchange Guide — Class II medical device recall Z-0528-2025
Ongoing recall by Smiths Medical ASD, Inc., reported 2024-12-04. Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingres
| Recall number | Z-0528-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Minneapolis, MN, United States |
| Recall initiated | 2024-10-28 |
| Classified | 2024-11-25 |
| Reported by FDA | 2024-12-04 |
| Quantity | 10,223 units |
| UPC / GTIN / UDI-DI | 35021239002586 |
| Lot numbers | 0003165, 0003184, 0003196, 0003204, 0003206, 0003226, 0003254, 0003256, 0003267, 0003300, 0003307, 0003308, 0003314, 0003322, 0003357, 0003358, 0003359, 0003360, 0003361, 0003362, 0003363, 0003364, 0003368, 0003369, 0003377, 0003380, 0003393, 0003394, 0003634, 0003635, 0003643 |
| Model numbers | 14-504-68, 14-504-68JP |
Product
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0528-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.