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.

76–100 of 100

HighFDA (Devices)·Z-0653-2022·2022-02-23
Smiths Medical Medfusion Syringe Infusion Pumps Recalled for Alarm System Failures
Smiths Medical is recalling certain Medfusion syringe infusion pumps due to intermittent alarm system failures that may occur during power-on self-tests outside the warranty period.
Product
Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0177-2022·2021-11-03
Bivona Aire-Cuf Endotracheal Tubes Recalled for Compromised Sterile Barrier
Smiths Medical is recalling 7136 Bivona Aire-Cuf Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. The issue affects specific lot numbers with 325mm shaft length.
Product
Bivona Aire-Cuf Endotracheal Tube
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0178-2022·2021-11-03
Bivona Uncuffed Endotracheal Tubes Recalled for Compromised Sterile Barrier
Smiths Medical ASD Inc. is recalling 2,191 Bivona Uncuffed Wire Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. Affected devices have 325mm shaft lengths and were distributed nationwide and internationally.
Product
Bivona Uncuffed Wire Endotracheal Tubes,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0163-2022·2021-11-03
Pneupac paraPac plus 300 ventilator kit recalled for duplicate serial number
Smiths Medical recalled two Pneupac paraPac plus 300 ventilator kits distributed in the UK that were labeled with the same serial number, preventing differentiation between the two units.
Product
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0107-2022·2021-10-27
Infusion Pump Air Detector Malfunction May Prevent Alarm to Clinician
Smiths Medical CADD-Solis VIP ambulatory infusion pumps may fail to detect air in the infusion line and alert clinicians due to intermittent air-detector malfunction.
Product
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-01
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0148-2022·2021-10-27
CADD Administration Sets with Incorrect Air Filter Assembly
Smiths Medical is recalling CADD Administration Sets (Model #21-7346-24) distributed in Canada because the air filter may have been assembled incorrectly. This manufacturing defect could impact device function.
Product
CADD Administration Sets, Model #21-7346-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0152-2022·2021-10-27
Smiths Medical Portex Loss of Resistance Device Lacks Sterilization and Reuse Labeling
Smiths Medical ASD Inc. is recalling the Portex Loss of Resistance Device because product labeling lacks information on sterilization procedures and does not prohibit reuse. The recall affects 3,420 devices distributed internationally.
Product
smiths medical portex Loss of Resistance Device, REF 100/398/000
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0155-2022·2021-10-27
medfusion Stopcock devices recalled due to sterility assurance deficiency
Smiths Medical is recalling over 933,000 medfusion Stopcock medical devices internationally due to lack of sterility assurance. The devices may not meet required sterility standards.
Product
medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0092-2022·2021-10-20
Medex LogiCal Closed Blood Sampling System Recalled for Pressure Reading Errors
Smiths Medical ASD Inc. is recalling medex LogiCal 5mL Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect patient safety.
Product
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0096-2022·2021-10-20
Smiths Medical LogiCal Blood Sampling Sets Recalled for Pressure Reading Errors
Smiths Medical ASD Inc. is recalling 870 units of LogiCal blood sampling sets distributed across Europe and Saudi Arabia due to reported pressure shifts and incorrect pressure readings.
Product
smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0100-2022·2021-10-20
Smiths Medical Antishunt Sets Recalled Due to Pressure and Reading Errors
Smiths Medical ASD Inc. is recalling approximately 20,800 Antishunt blood sampling sets due to reported pressure shifts and incorrect pressure readings. The affected model was distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
Product
smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0095-2022·2021-10-20
Blood Sampling System Recalled for Pressure Shifts and Incorrect Readings
Smiths Medical is recalling LogiCal Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings. Approximately 10,620 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
Product
smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0103-2022·2021-10-20
Smiths Medical Blood Sampling System Recalled for Pressure Malfunction and Incorrect Readings
Smiths Medical LogiCal MEDEX closed blood sampling system sets are recalled due to reported pressure shifts and incorrect pressure readings. Approximately 3,620 units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.
Product
smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0101-2022·2021-10-20
Blood sampling system sets recalled for pressure reading and measurement errors
Smiths Medical is recalling its medex blood sampling system sets due to pressure shifts and incorrect readings that may affect sample collection accuracy.
Product
smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0097-2022·2021-10-20
Smiths Medical CBSS blood sampling sets recalled for pressure measurement errors
Smiths Medical is recalling CBSS 5 ml blood sampling sets (Model DPSHC0083) due to reported pressure shifts and incorrect pressure readings. Approximately 7,080 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
Product
smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0098-2022·2021-10-20
Medical Device Recall: Blood Sampling System Pressure and Reading Errors
Smiths Medical is recalling LogiCal Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect blood collection accuracy.
Product
smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0093-2022·2021-10-20
Smiths Medical HemoDraw Plus Blood Sampling Sets Recalled for Pressure Monitoring Errors
Smiths Medical ASD Inc. is recalling 140 HemoDraw Plus Closed Blood Sampling Sets with LogiCal Pressure Monitoring System for pressure shifts and incorrect pressure readings. Affected units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.
Product
smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0094-2022·2021-10-20
Smiths Medical blood sampling system recalled for pressure measurement errors
Smiths Medical is recalling 3,100 units of its CBSS blood sampling system due to pressure measurement failures. The devices may show incorrect pressure readings or experience pressure shifts during use.
Product
smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0102-2022·2021-10-20
Smiths Medical blood sampling system recalled for pressure reading errors
Smiths Medical has recalled its Medex closed blood sampling system due to pressure shifts and incorrect pressure readings. Approximately 13,620 units were distributed internationally.
Product
smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0099-2022·2021-10-20
Smiths Medical closed blood sampling system sets recalled for pressure reading errors
Smiths Medical is recalling CBSS-5ML blood sampling system sets due to reported pressure shifts and incorrect pressure readings that may affect the accuracy of blood sample collection.
Product
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2376-2021·2021-09-15
NORMOFLO Irrigation Fluid Warmer Recalled for Risk of Aluminum Leaching
Smiths Medical recalls NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 (913 units) due to potential harmful aluminum leaching when used at lower flow rates with certain solutions and blood products.
Product
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2377-2021·2021-09-15
NORMOFLO Irrigation Warming Sets Recalled for Aluminum Leaching Risk
Smiths Medical is recalling NORMOFLO Irrigation Warming sets (Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) due to potential aluminum leaching when used at lower flow rates with certain solutions and blood products. No illnesses have been reported.
Product
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2401-2021·2021-09-08
Smiths Medical Tracheal Intubation Stylet Recall Due to Incorrect Device
Smiths Medical ASD Inc. is recalling 1,590 units of Smiths Medical Portex Tracheal Intubation Stylets because incorrect devices were found in packages. The affected lot was distributed internationally.
Product
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1993-2021·2021-07-07
Percutaneous Dilation Tracheostomy Kit Recalled for Incorrect Size Labeling
One lot of PORTEX ULTRperc Percutaneous Dilation Tracheostomy Kit (Lot 4072715) was incorrectly labeled as 7.0mm when it is 9.0mm. The 40 units were distributed in Pennsylvania, Michigan, Maryland, and Florida.
Product
PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1798-2021·2021-06-16
Jelco Insulin Syringe Graduation Markings Recalled for Skew Defect
Smiths Medical recalls 1,432,200 Jelco insulin syringes with skewed graduation markings that could lead to incorrect dosing. Specific lot numbers are affected.
Product
JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1
Category
Medical Device
Distribution
Distributed nationwide