Smiths Medical ASD Inc.
199 recalls on record · Latest: May 14, 2025
FDA Devices Moderate Nov 3, 2021
Bivona Aire-Cuf Endotracheal Tube
FDA Devices Moderate Oct 27, 2021
smiths medical portex Loss of Resistance Device, REF 100/398/000
FDA Devices Moderate Oct 27, 2021
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. 081-102RE g. 08…
FDA Devices Moderate Oct 20, 2021
smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
FDA Devices Moderate Oct 20, 2021
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
FDA Devices Moderate Oct 20, 2021
smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
FDA Devices Moderate Oct 20, 2021
smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
FDA Devices Moderate Oct 20, 2021
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
FDA Devices Moderate Oct 20, 2021
smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
FDA Devices Moderate Oct 20, 2021
smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
FDA Devices Critical Sep 15, 2021
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
FDA Devices Critical Sep 15, 2021
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
FDA Devices Moderate Sep 8, 2021
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
FDA Devices Critical Jun 16, 2021
JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF …
FDA Devices Moderate May 5, 2021
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters a…
FDA Devices Moderate Apr 28, 2021
Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
FDA Devices Moderate Apr 28, 2021
Left Heart Kit, Model Number M20268. for blood pressure monitoring.
FDA Devices Moderate Apr 28, 2021
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number M…
FDA Devices Moderate Apr 28, 2021
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
FDA Devices Moderate Apr 28, 2021
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
FDA Devices Moderate Apr 28, 2021
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model N…
FDA Devices Moderate Apr 28, 2021
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid …
FDA Devices Moderate Apr 28, 2021
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
FDA Devices Moderate Apr 28, 2021
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of ext…
FDA Devices Moderate Apr 28, 2021
HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.
FDA Devices Moderate Jul 15, 2020
PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
FDA Devices Moderate Jul 8, 2020
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
FDA Devices Moderate Apr 22, 2020
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
FDA Devices Moderate Apr 22, 2020
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
FDA Devices Moderate Oct 30, 2019
GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 2…
FDA Devices Moderate Oct 30, 2019
GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9M…
FDA Devices Moderate Oct 2, 2019
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; …
FDA Devices Moderate Jun 12, 2019
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex …
FDA Devices Moderate Jun 12, 2019
Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device inte…
FDA Devices Moderate Feb 27, 2019
Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, m…
FDA Devices Moderate Feb 27, 2019
Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4…
FDA Devices Low Oct 10, 2018
smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage…
FDA Devices Low Oct 10, 2018
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: …
FDA Devices Low Oct 10, 2018
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) …
FDA Devices Low Oct 10, 2018
smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For …
FDA Devices Low Sep 26, 2018
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the labe…
FDA Devices Moderate Aug 15, 2018
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
FDA Devices Moderate Jul 18, 2018
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbe…
FDA Devices Moderate Jun 13, 2018
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
FDA Devices Moderate Mar 28, 2018
Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiri…
FDA Devices Moderate Mar 28, 2018
Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiri…
FDA Devices Moderate Mar 28, 2018
Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiri…
FDA Devices Moderate Mar 21, 2018
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, 7FR/INTRO …
FDA Devices Moderate Feb 7, 2018
Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
FDA Devices Moderate Jan 10, 2018