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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.
September 16, 2020Medical DevicesFDA
Smiths Medical ASD Inc. recalls Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheo
Hazard: Label has the incorrect size for the tracheotomy tube.
August 12, 2020Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
Hazard: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
August 12, 2020Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Hazard: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
July 15, 2020Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
Hazard: Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.
July 8, 2020Medical DevicesFDA
Smiths Medical ASD Inc. recalls Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Hazard: One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
May 6, 2020Medical DevicesFDA
Smiths Medical ASD Inc. recalls Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide
Hazard: Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were labeled as 4824PL-20 instead of 4826PL-20.
April 22, 2020Medical DevicesFDA
Smiths Medical ASD, Inc. recalls Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Hazard: Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
April 22, 2020Medical DevicesFDA
Smiths Medical ASD, Inc. recalls Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
Hazard: Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
December 18, 2019Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. Th
Hazard: There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.
November 20, 2019Medical DevicesFDA
Smiths Medical ASD Inc. recalls ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
Hazard: Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.
October 30, 2019Medical DevicesFDA
Smiths Medical ASD Inc. recalls GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1.
Hazard: Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
October 30, 2019Medical DevicesFDA
Smiths Medical ASD Inc. recalls GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 1
Hazard: Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
October 2, 2019Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names
Hazard: Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on certain pumps due to a potential Radio Module issue on some Medfusion¿ 4000 pumps.
June 12, 2019Medical DevicesFDA
Smiths Medical ASD Inc. recalls Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a dispo
Hazard: Incorrect needle length and gage.
June 12, 2019Medical DevicesFDA
Smiths Medical ASD Inc. recalls Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part,
Hazard: Packaged with an incorrect size inner cannula.
May 1, 2019Medical DevicesFDA
Smiths Medical ASD Inc. recalls Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R)
Hazard: Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was made in the manufacturing process.
February 27, 2019Medical DevicesFDA
Smiths Medical ASD Inc. recalls Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Hepari
Hazard: The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
February 27, 2019Medical DevicesFDA
Smiths Medical ASD Inc. recalls Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin
Hazard: The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
December 5, 2018Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only
Hazard: Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924
October 10, 2018Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female L
Hazard: "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
October 10, 2018Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Lue
Hazard: "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
October 10, 2018Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-
Hazard: "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
October 10, 2018Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Sty
Hazard: "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
October 10, 2018Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear
Hazard: "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
September 26, 2018Medical DevicesFDA
Smiths Medical ASD Inc. recalls Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, R
Hazard: The product was mislabeled with the incorrect label.
August 15, 2018Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Hazard: Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.
July 18, 2018Medical DevicesFDA
Smiths Medical ASD Inc. recalls BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The dif
Hazard: Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature).
June 13, 2018Medical DevicesFDA
Smiths Medical ASD Inc. recalls Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Hazard: Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
March 28, 2018Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Adm
Hazard: Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size.
March 28, 2018Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Adm
Hazard: Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size.