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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.
October 18, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
Hazard: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
October 18, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump
Hazard: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
October 18, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0
Hazard: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
October 18, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 06
Hazard: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
October 18, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
Hazard: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
October 18, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Hazard: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
September 6, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Hazard: Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
May 24, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Po
Hazard: DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.
May 24, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elb
Hazard: DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.
May 24, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port f
Hazard: DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.
February 8, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24,
Hazard: There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
February 8, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24,
Hazard: There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
February 8, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP,
Hazard: There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
February 8, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5)
Hazard: There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
February 8, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Hazard: There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
November 30, 2022Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump
Hazard: Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
June 29, 2022Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-8
Hazard: Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001
June 29, 2022Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 40
Hazard: Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001
February 23, 2022Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during
Hazard: There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.
November 3, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls Bivona Uncuffed Wire Endotracheal Tubes,
Hazard: Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
November 3, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls Bivona Aire-Cuf Endotracheal Tube
Hazard: Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
November 3, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Hazard: Two devices were labeled with the same serial number
October 27, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 0
Hazard: Product has a lack of sterility assurance
October 27, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex Loss of Resistance Device, REF 100/398/000
Hazard: The labeling was missing information on sterilization and prohibition of reuse.
October 27, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD Administration Sets, Model #21-7346-24
Hazard: Product may have been manufactured with an air filter assembled in an incorrect orientation.
October 27, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L
Hazard: Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump and may not alarm to notify the clinician.
October 20, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
Hazard: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
October 20, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
Hazard: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
October 20, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Hazard: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
October 20, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
Hazard: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.