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Smiths Medical ASD Recalls
293 recalls on record · July 18, 2012 to May 14, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 7, 2015Medical DevicesFDA
Smiths Medical ASD, Inc. recalls Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Produc
Hazard: Needle is not captured in the needle safety sheath in specific lots.
January 7, 2015Medical DevicesFDA
Smiths Medical ASD, Inc. recalls Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safet
Hazard: Needle is not captured in the needle safety sheath in specific lots.
November 12, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-
Hazard: Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. CADD"-Solis Medication Safety Software Administrator 3.1 CDs were sent with the CADD"-Solis Medication Safety Software Point of Care 3.1 software loaded on them.
September 3, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
Hazard: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
September 3, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
Hazard: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
September 3, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
Hazard: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
September 3, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
Hazard: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
September 3, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
Hazard: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
September 3, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
Hazard: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
June 18, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal
Hazard: One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.
May 28, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended
Hazard: The hose could separate from the blanket.
April 16, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intra
Hazard: Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged
April 16, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intrave
Hazard: Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.
March 19, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, Needle-Pro¿
Hazard: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
March 19, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devi
Hazard: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
March 19, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip
Hazard: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
March 19, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line
Hazard: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
March 19, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in
Hazard: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
March 19, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls 4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in
Hazard: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
March 19, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls 4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in
Hazard: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
March 19, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls 4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial B
Hazard: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
March 19, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls 4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe ti
Hazard: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
March 19, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls 4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag
Hazard: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
March 19, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls 4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial
Hazard: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
March 19, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls 4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial
Hazard: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
March 19, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls 4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 2
Hazard: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
January 15, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardina
Hazard: Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes
January 15, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal
Hazard: Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes
January 15, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypo
Hazard: Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes
January 15, 2014Medical DevicesFDA
Smiths Medical ASD, Inc. recalls Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypo
Hazard: Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes