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.

226–250 of 293

  • ModerateFDA (Devices)·Z-2589-2017·2017-06-21

    Smiths Medical Recalls CADD High Volume Administration Sets Due to Incorrect Instructions

    Smiths Medical is recalling 7,035 CADD High Volume Administration Sets because they contained the wrong instruction manual insert.

    Product
    CADD¿ High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD¿ High-Volume Administration set is designed for use with the CADD¿ Prizm pump to allow fluid deliver from an IV bag.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1767-2017·2017-04-19

    Smiths Medical CADD Administration Set Recalled for Incorrect Filter Size Illustration

    Smiths Medical is recalling CADD Administration Sets because the illustration on the Instructions for Use incorrectly depicts the filter size as 2.0 microns instead of the actual 0.2 microns.

    Product
    CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-1465-2017·2017-03-22

    Smiths Medical Recalls Mislabelled Pediatric Tracheostomy Tubes

    Smiths Medical is recalling 142 Bivona TTS Pediatric Tracheostomy Tubes because they were incorrectly labeled for neonatal use instead of pediatric use.

    Product
    Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-1439-2017·2017-03-22

    Smiths Medical Recalls CADD Solis VIP Pumps for Mistranslated Message

    Smiths Medical ASD, Inc. is recalling 20 CADD Solis VIP Ambulatory Infusion Pumps sold in Finland due to a mistranslated error message. The pump's function is unchanged, and no patient injury can occur.

    Product
    CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1145-2017·2017-02-15

    FDA Recalls Hotline Blood and Fluid Warmers for Incorrect Language Labeling

    Smiths Medical ASD, Inc. is recalling 33 Hotline Blood and Fluid Warmers distributed to Finland because they included Greek and Danish labeling instead of the required Finnish labeling.

    Product
    HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditio
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1105-2017·2017-02-01

    Smiths Medical Recalls NORMFlow H-1100 Irrigation Fluid Warmer for Labeling Errors

    Smiths Medical is recalling one NORMFlow H-1100 Irrigation Fluid Warmer in Sweden due to incorrect Spanish labels instead of English.

    Product
    NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0789-2017·2016-12-28

    Smiths Medical Recalls Acuvance 2 Safety Catheters Due to Valve Defects

    Smiths Medical is recalling 26,750 Acuvance 2 Safety Catheters because some devices have missing or incorrectly positioned side port valves.

    Product
    Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipuncture on all patient populations where access to the veins and arteries are required. The cath
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1831-2016·2016-06-08

    Smiths Medical Recalls CADD Administration Sets with Flow Stop

    Smiths Medical is recalling CADD Administration Sets with Flow Stop because under-delivery of medication may occur. The recall affects 13,696,830 units distributed in the US and internationally.

    Product
    CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0152-2016·2015-10-28

    Smiths Medical Recalls Port-A-Cath Needles Due to Incorrect Labeling

    Smiths Medical ASD, Inc. is recalling Port-A-Cath Plastic Hub Needles from Lot 46262 because the lid stock labels contain incorrect part numbers, descriptions, and images.

    Product
    PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with stand
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2015·2015-06-24

    Smiths Medical Recalls CADD-Solis Pumps Due to Locking Assembly Binding

    Smiths Medical is recalling CADD-Solis Ambulatory Infusion Pumps because the locking assembly may bind, preventing the cassette or keypad from locking securely.

    Product
    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1730-2015·2015-06-17

    Smiths Medical Recalls Low Volume Extension Sets Due to Tubing Defect

    Smiths Medical is recalling 6,000 units of Low Volume Extension Sets because under-sized tubing was used in production. The affected product was distributed to five states.

    Product
    Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1692-2015·2015-06-10

    Smiths Medical Recalls BCI Advisor Vital Signs Monitors for Data Errors

    Smiths Medical is recalling 15 BCI Advisor Vital Signs Monitors because their auxiliary serial ports may transmit incorrect data to collection systems.

    Product
    Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1286-2015·2015-03-25

    Smiths Medical Recalls CADD Medication Cassette Reservoirs Due to Leak Risk

    Smiths Medical is recalling specific lots of 50mL CADD Medication Cassette Reservoirs because they may leak at the sealing area. No serious injuries or deaths have been reported.

    Product
    CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1028-2015·2015-02-04

    Smiths Medical Recalls Arterial Blood Sampling Kits Due to Labeling Error

    Smiths Medical ASD, Inc. is recalling 900 units of Portex Anaerobic Pulsator Arterial Blood Sampling Kits because the inner unit label displays an expiration date one year later than the actual date.

    Product
    Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, ele
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0897-2015·2015-01-07

    Smiths Medical Needle Pro Edge Safety Device Recall for Uncaptured Needles

    Smiths Medical ASD, Inc. is recalling specific lots of Needle Pro Edge Safety Devices because the needle is not captured in the safety sheath.

    Product
    Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0899-2015·2015-01-07

    Smiths Medical Recalls Hypodermic Needles Due to Safety Sheath Failure

    Smiths Medical ASD, Inc. is recalling 10,000 units of Needle Pro Edge Safety Hypodermic Needles because the needle may not be captured in the safety sheath.

    Product
    Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2015·2015-01-07

    Smiths Medical Recalls Hypodermic Needles Due to Safety Sheath Failure

    Smiths Medical ASD, Inc. is recalling specific lots of Needle Pro Edge safety hypodermic needles because the needle is not captured in the safety sheath.

    Product
    Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2015·2014-11-12

    Smiths Medical Recalls CADD-Solis Medication Safety Software Administrator CD

    Smiths Medical is recalling a specific lot of CADD-Solis Medication Safety Software Administrator CDs because they were shipped with incorrect software loaded.

    Product
    CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2541-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kit Tube Holders

    Smiths Medical ASD, Inc. is recalling H4052 Endo Tube Holders because the fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Devices)·Z-2536-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.

    Product
    4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-2539-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-2537-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-2540-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Compression

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • LowFDA (Devices)·Z-2538-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.

    Product
    H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • ModerateFDA (Devices)·Z-1641-2014·2014-06-18

    Smiths Medical Recalls Mislabelled Portex Low Dead Space Connectors

    Smiths Medical ASD, Inc. is recalling one lot of Portex Low Dead Space Connectors with Sideport because 3.0mm devices were packaged and labeled as 3.5mm.

    Product
    Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's
    Category
    Medical Device
    Distribution
    1 state