Skip to main content
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.
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Medical Devices·38,415 affected·Mar 17, 2017
High RiskFDA
Smiths Medical Asd Inc.
Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Medical Devices·142 affected·Feb 9, 2017
High RiskFDA
Smiths Medical Asd Inc.
Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
Medical Devices·641,070 affected·Dec 9, 2016
RecallFDA
Smiths Medical Asd, Inc.
HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood a...
Medical Devices·33 affected·Oct 31, 2016
High RiskFDA
Smiths Medical Asd, Inc.
PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are...
Medical Implants·130 affected·Sep 14, 2015
High RiskFDA
Smiths Medical Asd, Inc.
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provid...
Medical Devices·4,426 affected·May 26, 2015
High RiskFDA
Smiths Medical Asd Inc
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX ...
Medical Devices·6,000 affected·May 4, 2015
High RiskFDA
Smiths Medical Asd, Inc.
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Medical Devices·5 affected·Mar 21, 2015
CriticalFDA
Smiths Medical Asd, Inc.
CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
Medical Devices·48,208 affected·Feb 2, 2015
High RiskFDA
Smiths Medical Asd, Inc.
Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Nee...
Medical Devices·47,200 affected·Nov 21, 2014
High RiskFDA
Smiths Medical Asd, Inc.
Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Need...
Medical Devices·334,000 affected·Nov 21, 2014
High RiskFDA
Smiths Medical Asd, Inc.
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication ...
Medical Devices·24 affected·Sep 29, 2014
CriticalFDA
Smiths Medical Asd, Inc.
H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
Medical Devices·135,518 affected·Jul 7, 2014
High RiskFDA
Smiths Medical Asd, Inc.
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regul...
Cardiac Devices·2,120 affected·Apr 22, 2014
CriticalFDA
Smiths Medical Asd, Inc.
Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the pati...
Medical Devices·100 affected·Apr 10, 2014
High RiskFDA
Smiths Medical Asd, Inc.
Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at ...
Medical Devices·870 affected·Mar 17, 2014
High RiskFDA
Smiths Medical Asd, Inc.
Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at no...
Medical Devices·393,210 affected·Mar 17, 2014
High RiskFDA
Smiths Medical Asd, Inc.
4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial Blood Sampling Lin...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling L...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needl...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, Needle-Pro¿ Device and 23G x ...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blo...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) A...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) ...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Lue...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip s...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Japan only) ...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless othe...
Medical Devices·830 affected·Sep 23, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Portex¿ Saddleblock Tray with Drugs  25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless ...
Medical Devices·222 affected·Sep 23, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless other...
Medical Devices·3,980 affected·Sep 23, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family of products is comprised...
Medical Devices·200 affected·Sep 23, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro...
Diabetes Devices·506,925 affected·Jul 10, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro¿ Embryo Replacement Cathet...
Surgical Devices·4,910 affected·Mar 28, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are us...
Surgical Devices·59,089 affected·Mar 28, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo Replacement Cat...
Surgical Devices·22,380 affected·Mar 28, 2013
CriticalFDA
Smiths Medical Asd, Inc.
Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiratio...
Respiratory Devices·39 affected·Feb 6, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 B...
Medical Devices·2,247 affected·Jun 27, 2012
High RiskFDA
Smiths Medical Asd, Inc.
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of flu...
Medical Devices·6 affected·May 14, 2010