The Recall Desk

Manufacturer

Smiths Medical ASD, Inc.

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

What the numbers show

Total
293
Critical
9
Severe
71
Most recent
2025-05-14

Of the 293 recalls from Smiths Medical ASD, Inc. we have scored against our rubric, 9 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 71 (24%) are Severe.

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.

201–225 of 293

  • LowFDA (Devices)·Z-0071-2019·2018-10-10

    Smiths Medical Nasal Cannula Recalled for Transposed Date Labels

    Smiths Medical ASD Inc. is recalling 12,000 First Breath Adult Nasal Cannulas because the 'Manufactured' and 'Use By' labels are transposed, incorrectly suggesting the product expired before it was manufactured.

    Product
    smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0072-2019·2018-10-10

    Smiths Medical Nasal Cannula Recalled for Incorrect Labeling

    Smiths Medical ASD Inc. is recalling 2,550 adult nasal cannulas because the 'Manufactured' and 'Use By' labels are transposed, suggesting the product expired before it was manufactured.

    Product
    smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0073-2019·2018-10-10

    Smiths Medical Portex Nasal Cannula Recalled for Labeling Error

    Smiths Medical ASD Inc. is recalling 3,000 Portex First Breath Adult Nasal Cannulas because the 'Manufactured' and 'Use By' labels are transposed, suggesting the product expires before it was manufactured.

    Product
    smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0074-2019·2018-10-10

    Smiths Medical Portex Nasal Oxygen Cannula Recall for Labeling Error

    Smiths Medical ASD Inc. is recalling 13,750 Portex First Breath Nasal Oxygen Cannulas because the 'Manufactured' and 'Use By' labels are transposed, incorrectly suggesting the product expired before it was manufactured.

    Product
    smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3196-2018·2018-09-26

    Smiths Medical Recalls Mislabeled Arterial Blood Sampling Kits

    Smiths Medical ASD Inc. is recalling 29,600 Portex Pulsator Arterial Blood Sampling Kits because they were mislabeled with incorrect labels.

    Product
    Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2662-2018·2018-08-15

    Smiths Medical Recalls Medfusion Syringe Infusion Pumps with Defective Barrel Clamp Guides

    Smiths Medical ASD Inc. is recalling 276 Medfusion Syringe Infusion Pumps because a ridge in the Barrel Clamp Guide may cause spring slippage, preventing the pump from recognizing or correctly identifying loaded syringes.

    Product
    Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2379-2018·2018-07-18

    Smiths Medical Recalls BCI Advisor Vital Signs Monitors Due to Printing Defects

    Smiths Medical ASD Inc. is recalling 10 BCI Advisor Vital Signs Monitors because certain printing modes may not function properly.

    Product
    BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2018·2018-03-28

    Smiths Medical Medfusion Syringe Pumps Recalled for Syringe Misidentification

    Smiths Medical is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, preventing proper programming.

    Product
    Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2018·2018-03-28

    Smiths Medical Recalls Medfusion Syringe Pumps Due to Syringe Recognition Issues

    Smiths Medical is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.

    Product
    Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2018·2018-03-28

    Medfusion Syringe Pumps Recalled for Syringe Misidentification Risk

    Smiths Medical ASD Inc. is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.

    Product
    Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1073-2018·2018-03-21

    Smiths Medical Recalls Misassembled Port-A-Cath Implantable Port Kits

    Smiths Medical ASD Inc. is recalling certain Port-A-Cath II kits that may contain incorrect introducer sizes or locking collars due to misassembly.

    Product
    PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1074-2018·2018-03-21

    Smiths Medical Recalls Misassembled Power PORT-A-CATH II Implantable Port Kits

    Smiths Medical ASD Inc. is recalling 1,077 units of Power PORT-A-CATH II kits that may contain incorrect introducer sizes or locking collars.

    Product
    Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2018·2018-02-21

    Smiths Medical Recalls Single Custom Tracheostomy Device for Missing Sterilization

    Smiths Medical is recalling one custom tracheostomy device that was shipped without required sterilization. The device was distributed to a customer in Germany.

    Product
    Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0497-2018·2018-02-07

    Smiths Medical Recalls Graseby 3300 Pumps Due to Key Mismatch

    Smiths Medical is recalling 77 Graseby 3300 syringe pumps and accessories because the supplied lock and key may not match the standard key.

    Product
    Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0313-2018·2018-01-10

    Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Mechanism Defect

    Smiths Medical ASD Inc. is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.

    Product
    Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0307-2018·2018-01-10

    Smiths Medical CADD-Legacy 1 Pumps Recalled for Serial Number Mismatch

    Smiths Medical ASD Inc. is recalling 58 CADD-Legacy 1 Ambulatory Infusion Pumps because the physical label may not match the serial number programmed into the device software.

    Product
    CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0314-2018·2018-01-10

    Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Loosening

    Smiths Medical is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.

    Product
    Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2018·2017-11-08

    Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plates

    Smiths Medical is recalling CADD Medication Cassette Reservoirs because some units may have been manufactured with an incorrect pressure plate.

    Product
    CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2018·2017-11-08

    Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plate

    Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs because some units may have been manufactured with an incorrect pressure plate.

    Product
    CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0061-2018·2017-11-08

    Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plate

    Smiths Medical is recalling CADD Medication Cassette Reservoirs that may have been manufactured with an incorrect pressure plate. The recall covers units distributed worldwide.

    Product
    CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21-7002-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (excep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3213-2017·2017-10-04

    Smiths Medical Recalls UniPerc Tracheostomy Tube Kits with Incorrect Obturator Size

    Smiths Medical is recalling 89 UniPerc tracheostomy tube kits because they contain a 9.0mm obturator instead of the correct 8.0mm size.

    Product
    UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tub
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3071-2017·2017-09-06

    Smiths Medical CADD Medication Cassette Reservoir Recall for Manufacturing Defects

    Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs due to potential incorrect pressure plates and tubing routing.

    Product
    CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2759-2017·2017-08-02

    Smiths Medical CADD IV Administration Set Recalled for Missing Expiration Date

    Smiths Medical ASD Inc. is recalling CADD Blue-Striped IV Administration Sets in Canada because the labels are missing expiration dates.

    Product
    Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2670-2017·2017-07-12

    Smiths Medical Recalls Hypodermic Needles Due to Syringe Hub Defects

    Smiths Medical is recalling specific lots of Jelco Hypodermic Needle Pro needles because syringe assemblies used in their manufacture contained pin holes in the hub.

    Product
    Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
    Category
    Medical Device
    Distribution
    1 state