Smiths Medical ASD Inc.
199 recalls on record · Latest: May 14, 2025
FDA Devices Critical Sep 18, 2024
smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutan…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code…
FDA Devices Critical Sep 4, 2024
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Pr…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25;…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 6…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List N…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Co…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUB…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Co…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025;…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; …
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) A…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; …
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRA…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code…
FDA Devices Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
FDA Devices Critical Aug 14, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutan…
FDA Devices Moderate Apr 24, 2024
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4…
FDA Devices Moderate Apr 24, 2024
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
FDA Devices Moderate Apr 24, 2024
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) …
FDA Devices Critical Mar 27, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Devices Critical Mar 27, 2024
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Devices Critical Feb 7, 2024
smiths medical Medfusion Model 3500 Syringe pump
FDA Devices Critical Feb 7, 2024
smiths medical Medfusion Model 4000 syringe pump
FDA Devices Moderate Jan 24, 2024
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
FDA Devices Moderate Jan 24, 2024
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
FDA Devices Moderate Jan 24, 2024
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
FDA Devices Moderate Jan 24, 2024
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
FDA Devices Moderate Jan 24, 2024
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
FDA Devices Moderate Nov 8, 2023
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
FDA Devices Moderate Nov 1, 2023
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
FDA Devices Moderate Oct 18, 2023
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
FDA Devices Moderate Oct 18, 2023
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions…
FDA Devices Moderate Oct 18, 2023
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0…
FDA Devices Moderate Oct 18, 2023
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
FDA Devices Moderate May 24, 2023
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
FDA Devices Moderate May 24, 2023
DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing cir…
FDA Devices Critical Feb 8, 2023
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7…
FDA Devices Critical Feb 8, 2023
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
FDA Devices Critical Feb 8, 2023
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21…
FDA Devices Critical Feb 8, 2023
CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF …
FDA Devices Moderate Nov 30, 2022
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in…
FDA Devices Critical Jun 29, 2022
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-4…
FDA Devices Critical Jun 29, 2022
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-2…
FDA Devices Low Nov 3, 2021