FDA (Devices) recall action 94852
The FDA (Devices) publishes a recall like this one as 28 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 28 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Smiths Medical recalls specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, potentially affecting tube positioning.
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. The recall affects neonatal, pediatric, and adult versions distributed worldwide.
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. Products distributed worldwide.
PORTEX Bivona Tracheostomy Tubes (3.0mm, 3.5mm, 4.0mm) are being recalled due to a manufacturing defect that may cause the securement flange to tear. This could result in airway obstruction or loss of tube securement.
Smiths Medical is recalling specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes because the securement flange may tear due to a manufacturing defect.
Smiths Medical is recalling specific lots of PORTEX Bivona pediatric and neonatal tracheostomy tubes because the securement flange may tear due to a manufacturing defect. The recall affects multiple tube sizes distributed worldwide.
Smiths Medical is recalling specific lots of PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear, affecting device positioning.
Smiths Medical is recalling specific lots of Bivona tracheostomy tubes because the securement flange may tear due to a manufacturing defect.
Smiths Medical is recalling specific lots of Bivona tracheostomy tubes because the securement flange may tear due to a manufacturing defect.
Smiths Medical is recalling specific lots of Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect.
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because a manufacturing defect may cause the securement flange to tear.
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. These tubes are used for neonatal, pediatric, and adult patients worldwide.
Smiths Medical recalls pediatric tracheostomy tubes from specific lots due to a manufacturing defect that may cause the securement flange to tear. No injuries have been reported.
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because of a manufacturing defect that may cause the securement flange to tear.
Smiths Medical is recalling PORTEX Bivona neonatal and pediatric tracheostomy tubes worldwide due to a manufacturing defect in the securement flange that may tear and affect proper positioning.
Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, risking loss of airway securement.
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. This affects pediatric and adult sizes distributed worldwide.
Smiths Medical is recalling PORTEX Bivona Tracheostomy Silicone Tubes because the securement flange may tear due to a manufacturing defect. The defect affects multiple lot numbers across all size variants distributed worldwide.
Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect in the securement flange, which may tear. Affected patients should discontinue use and contact their healthcare provider.
Smiths Medical is recalling specific lots of Bivona Neonatal and Pediatric Tracheostomy Tubes because the securement flange may tear due to manufacturing defects.
Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to manufacturing defect that may cause securement flange to tear, compromising tube stability.
Smiths Medical is recalling specific lots of Bivona Neonatal, Pediatric, and Adult Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, potentially compromising tube security.
Smiths Medical recalled specific lots of Bivona Tracheostomy Tubes after identifying a manufacturing defect that may cause the securement flange to tear, risking tube displacement.
Smiths Medical recalled specific lots of PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products were distributed worldwide.
Smiths Medical recalls PORTEX Bivona tracheostomy tubes due to a manufacturing defect that may cause the securement flange to tear, potentially leading to tube dislodgement.