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Smiths Medical Asd Inc. Recalls

182 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Smiths Medical Asd Inc..

182Total Recalls
58Critical
183.5MUnits Affected
Apr 10, 2025Most Recent
All Recalls

Every Smiths Medical Asd Inc. Recall

Sorted by most recent. Click any recall for full details.

182 recalls
CriticalFDA
Smiths Medical Asd Inc.
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOM...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT N...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code ...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item C...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Nu...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONAT...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Nu...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) ...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Co...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
Medical Devices·3,138 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 6...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750...
Medical Devices·25,283 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code ...
Medical Devices·36,219 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) ...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Numb...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Ite...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arteri...
Medical Devices·0 affected·Feb 27, 2024
CriticalFDA
Smiths Medical Asd Inc.
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
Respiratory Devices·10,140 affected·Feb 7, 2024
CriticalFDA
Smiths Medical Asd Inc.
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
Respiratory Devices·2,902 affected·Feb 7, 2024
CriticalFDA
Smiths Medical Asd Inc.
smiths medical Medfusion Model 3500 Syringe pump
Medical Devices·93,177 affected·Dec 19, 2023
High RiskFDA
Smiths Medical Asd Inc.
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105...
Medical Devices·7,160 affected·Dec 19, 2023
CriticalFDA
Smiths Medical Asd Inc.
smiths medical Medfusion Model 4000 syringe pump
Medical Devices·60,146 affected·Dec 19, 2023
High RiskFDA
Smiths Medical Asd Inc.
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Medical Devices·1,842 affected·Dec 19, 2023
High RiskFDA
Smiths Medical Asd Inc.
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-...
Medical Devices·3,821 affected·Dec 19, 2023
High RiskFDA
Smiths Medical Asd Inc
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Medical Devices·31,685 affected·Nov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
Medical Devices·31,685 affected·Nov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Medical Devices·31,685 affected·Nov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
Medical Devices·31,685 affected·Nov 10, 2023
High RiskFDA
Smiths Medical Asd Inc.
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Medical Devices·31,900 affected·Sep 6, 2023
High RiskFDA
Smiths Medical Asd Inc.
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Medical Devices·0 affected·Aug 22, 2023
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Medical Devices·20,815 affected·Aug 16, 2023
High RiskFDA
Smiths Medical Asd Inc.
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; softw...
Medical Devices·20,383 affected·Aug 16, 2023
High RiskFDA
Smiths Medical Asd Inc.
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) 010...
Medical Devices·67,507 affected·Aug 16, 2023
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
Medical Devices·111 affected·Aug 16, 2023
High RiskFDA
Smiths Medical Asd Inc.
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breat...
Medical Devices·47,007 affected·Apr 5, 2023
High RiskFDA
Smiths Medical Asd Inc.
DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with b...
Medical Devices·14,941 affected·Apr 5, 2023
CriticalFDA
Smiths Medical Asd Inc.
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, ...
Medical Devices·45,285,351 affected·Dec 9, 2022
CriticalFDA
Smiths Medical Asd Inc.
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Medical Devices·1,616,714 affected·Dec 9, 2022
CriticalFDA
Smiths Medical Asd Inc.
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...
Medical Devices·47,595,495 affected·Dec 9, 2022
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP...
Medical Devices·422 affected·Oct 10, 2022
CriticalFDA
Smiths Medical Asd Inc.
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...
Medical Devices·65,093 affected·Apr 18, 2022
CriticalFDA
Smiths Medical Asd Inc.
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...
Medical Devices·58,671 affected·Apr 18, 2022
High RiskFDA
Smiths Medical Asd Inc.
Bivona Aire-Cuf Endotracheal Tube
Medical Devices·7,136 affected·Aug 9, 2021
CriticalFDA
Smiths Medical Asd Inc.
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Medical Devices·519,250 affected·Aug 6, 2021
RecallFDA
Smiths Medical Asd Inc.
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Respiratory Devices·2 affected·Jul 15, 2021