Brand
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
High RiskFDA
Smiths Medical Asd Inc.
Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressur...
Medical Devices11,340 affectedMar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Left Heart Kit, Model Number M20268. for blood pressure monitoring.
Cardiac Devices600 affectedMar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Mo...
Medical Devices3,825 affectedMar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
Medical Devices200 affectedMar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
Cardiac Devices3,740 affectedMar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HAN...
Medical Devices1,380 affectedMar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction ...
Medical Devices400 affectedMar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
Medical Devices500 affectedMar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler...
Respiratory Devices250 affectedMar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. comp...
Medical Devices8,150 affectedMar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.
Medical Devices275 affectedMar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex Loss of Resistance Device, REF 100/398/000
Medical Devices3,420 affectedDec 8, 2020
High RiskFDA
Smiths Medical Asd Inc.
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Medical Devices20 affectedMay 26, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Medical Devices150 affectedMar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
Medical Devices20 affectedMar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
Medical Devices13,620 affectedMar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
Medical Devices870 affectedMar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Medical Devices17,980 affectedMar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
Medical Devices3,620 affectedMar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
Medical Devices3,100 affectedMar 10, 2020
High RiskFDA
Smiths Medical Asd, Inc.
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Medical Devices127,700 affectedJan 7, 2020
High RiskFDA
Smiths Medical Asd, Inc.
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
Medical Devices720,100 affectedJan 7, 2020
High RiskFDA
Smiths Medical Asd Inc.
GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL...
Medical Devices3,952,425 affectedJul 8, 2019
High RiskFDA
Smiths Medical Asd Inc.
GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, ...
Medical Devices3,952,509 affectedJul 8, 2019
High RiskFDA
Smiths Medical Asd Inc.
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: ...
Medical Devices7,840 affectedFeb 11, 2019
High RiskFDA
Smiths Medical Asd Inc.
Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use...
Medical Devices109,000 affectedFeb 11, 2019
High RiskFDA
Smiths Medical Asd Inc.
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000...
Medical Devices20,884 affectedOct 15, 2018
RecallFDA
Smiths Medical Asd Inc.
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name...
Medical Devices29,600 affectedJul 13, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. P...
Respiratory Devices3,000 affectedJul 6, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Prod...
Respiratory Devices12,000 affectedJul 6, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 21...
Respiratory Devices850 affectedJul 6, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product ...
Respiratory Devices2,550 affectedJul 6, 2018
High RiskFDA
Smiths Medical Asd Inc.
Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Ele...
Medical Devices28,578,939 affectedJun 22, 2018
High RiskFDA
Smiths Medical Asd Inc.
Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-...
Medical Devices28,578,939 affectedJun 22, 2018
High RiskFDA
Smiths Medical Asd Inc.
medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-...
Medical Devices933,518 affectedMay 10, 2018
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Medical Devices276 affectedApr 13, 2018
High RiskFDA
Smiths Medical Asd Inc.
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Medical Devices16 affectedApr 2, 2018
High RiskFDA
Smiths Medical Asd Inc.
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK...
Medical Devices1,077 affectedDec 4, 2017
High RiskFDA
Smiths Medical Asd Inc.
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the r...
Medical Devices10 affectedNov 29, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Medical Devices58 affectedNov 22, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fl...
Medical Devices16,600 affectedNov 13, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fl...
Medical Devices16,600 affectedNov 13, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fl...
Medical Devices16,600 affectedNov 13, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (exc...
Medical Devices11,170,535 affectedSep 25, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pembe...
Medical Devices9,787 affectedAug 22, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pem...
Medical Devices9,787 affectedAug 22, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manu...
Medical Devices17,280 affectedJun 5, 2017
High RiskFDA
Smiths Medical Asd Inc.
Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
Medical Devices736,000 affectedApr 4, 2017