PORTEX Bivona Tracheostomy Silicone Tube — Class I medical device recall Z-2612-2024

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-2612-2024`
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	`10351688518545`, `10351688518552`, `10351688518569`, `10351688518576`, `10351688518583`
Lot numbers	`3802149`, `3802150`, `3832051`, `3853396`, `3853397`, `3853398`, `3853399`, `3853400`, `3853401`, `3853402`, `3864259`, `3868254`, `3868255`, `3868256`, `3868269`, `3868287`, `3871037`, `3871040`, `3871049`, `3874313`, `3874321`, `3877646`, `3877662`, `3877671`, `3880684`, `3880685`, `3880700`, `3887725`, `3887730`, `3887734`, `3887735`, `3891536`, `3894880`, `3894881`, `3894892`, `3894893`, `3894912`, `3901306`, `3904651`, `3904657` and 245 more
Model numbers	`67PFPS40`, `67PFPS45`, `67PFPS50`, `67PFPS55`, `67PFPS60`

Product

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60

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-2612-2024. 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.