PORTEX Bivona Tracheostomy Silicone Tube — Class I medical device recall Z-2609-2024

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 number	`Z-2609-2024`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Smiths Medical ASD Inc., Minneapolis, MN, United States
Recall initiated	2024-05-29
Classified	2024-08-23
Reported by FDA	2024-09-04
UPC / GTIN / UDI-DI	`10351688518774`, `10351688518781`, `10351688518798`, `10351688518804`
Lot numbers	`3853382`, `3853383`, `3853384`, `3853385`, `3868267`, `3871038`, `3877674`, `3880680`, `3880695`, `3884238`, `3884239`, `3884243`, `3887729`, `3891516`, `3891517`, `3894911`, `3894915`, `3901286`, `3901295`, `3904649`, `3904650`, `3911417`, `3917994`, `3918017`, `3926972`, `3930028`, `3930044`, `3936565`, `3939648`, `3939649`, `3939651`, `3939657`, `3942536`, `3942542`, `3942543`, `3946254`, `3952395`, `3952409`, `3952411`, `3952413` and 160 more
Model numbers	`67NFPS25`, `67NFPS30`, `67NFPS35`, `67NFPS40`

Product

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40

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-2609-2024. 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.