Data Foundry

Medical device recalls 2024

PORTEX Bivona Tracheostomy Silicone Tube — Class I medical device recall Z-2588-2024

Ongoing recall by Smiths Medical ASD Inc., reported 2024-09-04. Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and

Recall numberZ-2588-2024
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSmiths Medical ASD Inc., Minneapolis, MN, United States
Recall initiated2024-05-29
Classified2024-08-23
Reported by FDA2024-09-04
Quantity177,340 units
UPC / GTIN / UDI-DI15021312006056, 15021312006070
Lot numbers3774400, 3774401, 3774402, 3774406, 3774411, 3774412, 3774413, 3778527, 3778528, 3778529, 3778530, 3778531, 3778532, 3778533, 3778534, 3778535, 3782488, 3782489, 3782490, 3782491, 3782492, 3782494, 3782495, 3782496, 3782497, 3782498, 3782500, 3790009, 3790010, 3790011, 3790012, 3790013, 3790014, 3790015, 3790016, 3790017, 3790081, 3790082, 3790083, 3790084 and 460 more
Model numbers670170, 670180

Product

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

Reason for recall

Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

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-2588-2024. 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.