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.

176–200 of 293

  • HighFDA (Devices)·Z-1478-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Tubing Due to Weld Defects

    Smiths Medical ASD Inc. is recalling specific lots of Medex high pressure tubing and components due to insufficient or incomplete welds.

    Product
    HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1475-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

    Smiths Medical is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to potential manufacturing defects in welds.

    Product
    ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1145-2021·2021-03-03

    Smiths Medical Recalls Bivona Cuffless FlexTend Tracheostomy Tubes Due to Packaging Error

    Smiths Medical is recalling specific lots of Bivona Cuffless FlexTend Tracheostomy Tubes because they may have been packaged with the wrong neck flange, posing a risk of patient injury.

    Product
    Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0874-2021·2021-01-27

    Smiths Medical Recalls Portex Acapella DH Vibratory PEP Devices

    Smiths Medical ASD Inc. is recalling 4,440 Portex Acapella DH Vibratory PEP Devices because shipping boxes may contain the wrong model number.

    Product
    Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0726-2021·2021-01-06

    Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Packaging Error

    Smiths Medical is recalling 238 Bivona Cuffless FlexTend Tracheostomy Tubes because they may have been incorrectly packaged with a V-neck flange instead of a straight flange.

    Product
    PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2946-2020·2020-09-16

    Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Incorrect Size Labeling

    Smiths Medical ASD Inc. is recalling three Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tubes because the labels display the incorrect size. The units were distributed in Connecticut.

    Product
    Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2734-2020·2020-08-12

    Smiths Medical Medfusion Syringe Pump Recall for Inaccurate Dose Delivery

    Smiths Medical is recalling Medfusion Syringe Pump Model 4000 units due to a risk of inaccurate drug delivery following interrupted bolus or loading doses.

    Product
    Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2735-2020·2020-08-12

    Smiths Medical Medfusion Syringe Pump Recall for Inaccurate Delivery

    Smiths Medical is recalling Medfusion Syringe Pump Model 3500 units because inaccurate delivery can occur after an interrupted Bolus or Loading dose.

    Product
    Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1820-2020·2020-05-06

    Smiths Medical Recalls Mislabeled Portex Lumbar Puncture Trays

    Smiths Medical ASD Inc. is recalling 100 units of Portex Lumbar Puncture Trays because the inner trays were mislabeled with an incorrect model number.

    Product
    Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary to measure cerebrospinal fluid pressure and/or collect cerebrospinal fluid specimens. Key components include skin prep materials, la
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1715-2020·2020-04-22

    Smiths Medical Recalls Portex Arterial Blood Sampling Syringes with Broken Luer

    Smiths Medical ASD, Inc. is recalling Portex LineDraw Arterial Blood Sampling Syringes because the luer connectors may be broken.

    Product
    Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1716-2020·2020-04-22

    Smiths Medical Recalls Arterial Blood Sampling Kits with Broken Luer Defect

    Smiths Medical is recalling Portex Pro-Vent Arterial Blood Sampling Kits because some lots may have broken luer connectors.

    Product
    Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-0610-2020·2019-12-18

    Smiths Medical Medfusion 4000 Syringe Pump Firmware Recall

    Smiths Medical is recalling 626 Medfusion 4000 Syringe Pumps due to a firmware anomaly that may disable battery alarms and interrupt therapy.

    Product
    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0352-2020·2019-11-20

    Smiths Medical Recalls ProtectIV Plus Safety IV Catheters

    Smiths Medical is recalling certain lots of ProtectIV Plus Safety IV Catheters because the safety mechanism guard may be damaged.

    Product
    ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0189-2020·2019-10-30

    Smiths Medical Recalls GRIPPER Needles Due to Potential Occlusion

    Smiths Medical ASD Inc. is recalling GRIPPER Needles because some may be occluded or blocked, posing a risk to patients.

    Product
    GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.25" (32MM), 12/BX; 4. NDL, GRIPPER, 19G X 1" (25MM), 12/BX; 5. ND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0190-2020·2019-10-30

    Smiths Medical Recalls GRIPPER Needles Due to Potential Occlusion

    Smiths Medical ASD Inc. is recalling GRIPPER Needles from the PORT-A-CATH II system because they may be occluded or blocked.

    Product
    GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM, CS,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2554-2019·2019-10-02

    Smiths Medical Medfusion 4000 Syringe Infusion Pump Recall for Wireless Connectivity Issues

    Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps with PharmGuard Server Software due to potential wireless network connectivity issues caused by a Radio Module defect.

    Product
    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1733-2019·2019-06-12

    Smith Medical JELCO Hypodermic Needle Recall for Incorrect Specifications

    Smiths Medical ASD Inc. is recalling JELCO Hypodermic Needles with incorrect length and gauge. The recall covers 109,000 units distributed nationwide.

    Product
    Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1732-2019·2019-06-12

    Smiths Medical Recalls Portex Tracheostomy Tubes with Incorrect Inner Cannula Size

    Smiths Medical ASD Inc. is recalling 7,840 Portex Blue Line Ultra Tracheostomy Tubes because they were packaged with an incorrect size inner cannula.

    Product
    Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1218-2019·2019-05-01

    Jelco ViaValve Safety Intravenous Catheters Recalled for Manufacturing Defect

    Smiths Medical ASD Inc. is recalling specific lots of Jelco ViaValve safety intravenous catheters due to a V-shaped puncture at the base of the catheter.

    Product
    Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular catheter device used for the administration of medically pre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0843-2019·2019-02-27

    Smiths Medical Recalls Arterial Blood Sampling Kits Due to Iodine Potency

    Smiths Medical ASD Inc. is recalling Portex Pulsator Arterial Blood Sampling Kits because the included povidone iodine prep pads may not maintain potency through their expiration dates.

    Product
    Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, and G1806.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0842-2019·2019-02-27

    Smiths Medical Recalls Arterial Blood Sampling Kits with Povidone Iodine Pads

    Smiths Medical ASD Inc. is recalling arterial blood sampling kits because the included povidone iodine prep pads may not maintain potency through their expiration dates.

    Product
    Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0512-2019·2018-12-05

    Smiths Medical Recalls Medex High Pressure Stopcocks Due to Leak Risk

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Stopcocks because an inner body defect may cause the device to leak.

    Product
    Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0075-2019·2018-10-10

    Smiths Medical Portex Nasal Oxygen Cannula Recalled for Labeling Error

    Smiths Medical ASD Inc. is recalling 850 Portex First Breath Nasal Oxygen Cannulas because the 'Manufactured' and 'Use By' dates are transposed, incorrectly suggesting the product expired before it was made.

    Product
    smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female 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