Smiths Medical Asd, Inc.
Gary, IN
This page shows every FDA and USDA recall linked to Smiths Medical Asd, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
28
Total Recalls
2005
First Recall
2016
Most Recent
Custom Made Tracheostomy Device
The CADD Administration Sets with Flow Stop are designed to be used with a va...
Jul 15, 2016
· Device
Terminated
Bivona TTS Cuffed Pediatric Tracheostomy Tube
Sizes 2.5 - 5.5 (With a Straight Neck Flange)
Product Usage:...
Jan 19, 2012
· Device
Terminated
Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flan...
Jan 19, 2012
· Device
Terminated
Bivona Uncuffed Neonatal Tracheostomy Tube
Sizes 2.5 - 4.0 (With a Straight Neck Flange)
Product Usage: Th...
Jan 19, 2012
· Device
Terminated
Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange)
Jan 19, 2012
· Device
Terminated
Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange)
Product Usage: Th...
Jan 19, 2012
· Device
Terminated
Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange)
Product Usage:...
Jan 19, 2012
· Device
Terminated
Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange).
Jan 19, 2012
· Device
Terminated
Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5
Product Usage: This tube is intended to provide...
Jan 19, 2012
· Device
Terminated
Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange)
Prod...
Jan 19, 2012
· Device
Terminated
Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (With a V-Shaped Neck...
Jan 19, 2012
· Device
Terminated
Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flan...
Jan 19, 2012
· Device
Terminated
Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5
Product Usage: This tube is intended to provide...
Jan 19, 2012
· Device
Terminated
Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange)
Pro...
Jan 19, 2012
· Device
Terminated
Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange)
Product Usage: Thi...
Jan 19, 2012
· Device
Terminated
Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (With a Straight Neck...
Jan 19, 2012
· Device
Terminated
Bivona TTS Cuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange)
Product Usage: T...
Jan 19, 2012
· Device
Terminated
Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical C...
Jan 25, 2007
· Device
Terminated
Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Cr...
Jan 5, 2007
· Device
Terminated
Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by S...
Dec 7, 2006
· Device
Terminated
Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths...
Oct 19, 2006
· Device
Terminated
Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm...
Jan 18, 2006
· Device
Terminated
Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm le...
Jan 18, 2006
· Device
Terminated
Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 130 mm; RE...
Jan 18, 2006
· Device
Terminated
Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AF...
Jan 6, 2006
· Device
Terminated
Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
Dec 23, 2005
· Device
Terminated
Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
Dec 23, 2005
· Device
Terminated
Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code...
Jun 25, 2005
· Device
Terminated