Manufacturer

Smiths Medical ASD Inc.

100 recalls in our database name Smiths Medical ASD Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 100

HighFDA (Devices)·Z-1540-2024·2024-04-24
Smiths Medical Medfusion Syringe Pumps May Fail to Recognize Syringes
Smiths Medical is recalling certain Medfusion Models 4000, 3500, and 3010 syringe pumps due to a barrel clamp guide defect. The defect may prevent the pump from recognizing or correctly identifying a syringe, potentially affecting medication delivery.
Product
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1274-2024·2024-03-27
Smiths Medical Pneupac paraPAC plus 310 ventilators recalled for malfunction
Smiths Medical is recalling paraPAC plus 310 ventilators that may malfunction by delivering continuous gas flow instead of cycling breaths. The defect affects 10,140 units distributed worldwide and prevents proper ventilation.
Product
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1275-2024·2024-03-27
Smiths Medical Pneupac Plus 300 Ventilator Cycling Malfunction
Smiths Medical Pneupac Plus 300 ventilators may intermittently deliver continuous airflow instead of cycling breaths as designed. This malfunction affects 2,902 units distributed worldwide.
Product
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0864-2024·2024-02-07
Smiths Medical Medfusion 4000 Syringe Pump Software Defects Recall
The FDA is recalling Smiths Medical Medfusion Model 4000 syringe pumps due to software defects affecting medication delivery, alarms, and display accuracy. Users should install the latest software version to correct these issues.
Product
smiths medical Medfusion Model 4000 syringe pump
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0863-2024·2024-02-07
Smiths Medical Medfusion Model 3500 Syringe Pump Software Defects
Smiths Medical recalls Medfusion Model 3500 syringe pumps (software versions before v6.0.0) due to multiple programming defects that could affect medication delivery rates, timing, and accuracy.
Product
smiths medical Medfusion Model 3500 Syringe pump
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0205-2024·2023-11-08
Pediatric Tracheostomy Tube Recalled Due to Incorrect Box Expiration Date Label
Smiths Medical recalls a pediatric tracheostomy tube because the outer box shows an incorrect expiration date (3/17/2021) while the actual product has the correct date (3/17/2026). The discrepancy could cause confusion about product validity.
Product
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0141-2024·2023-11-01
Smiths Medical Blood Sampling Kits Missing Critical Filter Component
Smiths Medical is recalling 31,900 Portex Pro-Vent Arterial Blood Sampling Kits due to missing filter components. Kits without the filter can produce inaccurate test results or expose users to infectious blood.
Product
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0078-2024·2023-10-18
Syringe Pump Force Sensor Drift May Cause Detection Delays or False Alarms
Smiths Medical Medfusion syringe pumps may have force sensors that drift out of calibration, causing delays in detecting line occlusions or triggering false alarms. Devices produced before April 2022 are at higher risk.
Product
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0077-2024·2023-10-18
Medfusion Syringe Pump Sensor Calibration Drift May Cause False Alarms
Smiths Medical is recalling Medfusion Model 3500VX-500 Syringe Pumps due to force sensor calibration drift that can cause false alarms, system failures, or delayed occlusion detection.
Product
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0081-2024·2023-10-18
Infusion pump component force sensor may malfunction or trigger false alarms
Smiths Medical is recalling 118 units of Medfusion infusion pump plunger case components due to potential force sensor calibration drift. The sensor may malfunction, leading to delayed occlusion detection, false alarms, or system failure.
Product
Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0079-2024·2023-10-18
Medfusion Syringe Pump Recalled for Occlusion Detection Calibration Drift
Smiths Medical is recalling Medfusion Syringe Pumps due to force sensor calibration drift that may delay occlusion detection or trigger false alarms. About 67,507 pumps are affected, distributed in the US and Canada.
Product
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-78, i) 0105-249, j) 0106-00, k) 0106-01, l) 0106-231, m) 0107-01, software versions: v3, v4, v5, and v6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0080-2024·2023-10-18
Medfusion Infusion Pump Plunger Sensor Calibration Drift Recall
Smiths Medical is recalling Medfusion infusion pump components due to a force sensor calibration issue that may cause delayed occlusion detection, false alarms, or system failures. No injuries have been reported.
Product
Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0076-2024·2023-10-18
Medfusion Syringe Pumps Recalled for Force Sensor Calibration Drift
The Medfusion Syringe Pump Model 3500-500 may experience force sensor calibration drift, causing false alarms or delayed occlusion detection. Approximately 20,815 units are being recalled worldwide, with increased risk in devices manufactured before April 2022.
Product
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2466-2023·2023-09-06
Medical filter barcode does not match product expiration date
Smiths Medical recalls 66,633 PORTEX 0.5u Hydrophobic Disc Filters nationwide due to a labeling error where the barcode (UDI) does not correctly reflect the product expiration date.
Product
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1582-2023·2023-05-24
FDA Recalls DuraLife Silicone Breathing Tube Extension Over Sterilization Guidance
Smiths Medical ASD recalled 14,941 DuraLife silicone extension tubes worldwide due to incomplete sterilization instructions that could compromise patient safety.
Product
DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1581-2023·2023-05-24
DuraLife Breathing Circuit Extension Tube Recall Due to Inadequate Sterilization Instructions
Smiths Medical is recalling 2,101 DuraLife Autoclavable Silicone Extension Tubes due to inadequate sterilization instructions. The product documentation does not specify cleaning methods, autoclave cycle duration, or the number of reuse cycles allowed per patient.
Product
DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1580-2023·2023-05-24
Breathing circuit swivel elbow recalled for inadequate sterilization instructions
Smiths Medical is recalling DuraLife Swivel Elbow breathing circuit devices due to inadequate sterilization instructions. The device instructions lack cleaning methods, autoclave cycle duration, and reuse specifications.
Product
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0963-2023·2023-02-08
CADD Infusion Administration Sets Recalled for Tubing Occlusion and False Alarms
Smiths Medical is recalling CADD Administration Sets for two issues: tubing may become blocked, preventing medication delivery, and devices may show false alerts about disposable attachment status.
Product
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) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0962-2023·2023-02-08
CADD Administration Set recall: medication underdelivery and false alarms
Smiths Medical is recalling 1.6 million CADD Infusion System Administration Sets due to tubing occlusion causing medication underdelivery and false alarm conditions affecting patients worldwide.
Product
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0966-2023·2023-02-08
CADD Administration Sets recall for delivery failure and false alarms
Smiths Medical is recalling CADD Administration Sets due to potential tubing occlusion causing medication underdelivery and false alarm errors. The FDA classified this as a Class I recall affecting nearly 48 million units worldwide.
Product
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, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0965-2023·2023-02-08
CADD Infusion Administration Set Recalled for Delivery Failure and False Alarms
Smiths Medical is recalling CADD Administration Sets due to tubing occlusion that can prevent medication delivery and false pump alarms. This FDA Class I recall affects 214,668 units worldwide.
Product
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, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0964-2023·2023-02-08
CADD Infusion Administration Sets Recalled for Delivery Failure and Alarms
FDA recalls 726,878 CADD Infusion Administration Sets due to potential tubing occlusion causing delivery failure and false alarm warnings.
Product
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, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0272-2023·2022-11-30
Medfusion 4000 Syringe Pump May Delay Sending EHR Infusion Start Messages
Smiths Medical's Medfusion 4000 infusion pump software may delay sending infusion start messages to Electronic Health Record systems, potentially affecting infusion programming and clinical documentation.
Product
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1271-2022·2022-06-29
Medfusion Syringe Pump Recalled Due to Multiple Infusion Control and Alarm Failures
Smiths Medical recalled 58,671 Medfusion Syringe Pump units worldwide due to multiple failures that could interrupt therapy or cause over-infusion, including defective alarms and display errors.
Product
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1272-2022·2022-06-29
Medfusion Syringe Pump Class I Recall: Risk of Over-Infusion or Therapy Interruption
Smiths Medical is recalling multiple Medfusion Syringe Pump models due to software and hardware defects that may interrupt drug infusion or cause over-infusion. Approximately 65,093 units distributed worldwide are affected.
Product
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, S
Category
Medical Device
Distribution
Distributed nationwide