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
83
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 83 (28%) 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.

51–75 of 293

  • HighFDA (Devices)·Z-0187-2025·2024-10-30

    Smiths Medical Arterial Kit recalled for pressure monitoring defect

    Smiths Medical ASD is recalling medex Arterial Kits due to a manufacturing defect in the TranStar Disposable Pressure Transducer that may cause inaccurate readings or device failure.

    Product
    medex Arterial Kit 1/EA, Product Code REF MX7827
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0194-2025·2024-10-30

    Smiths Medical TranStar Pressure Transducers Recalled Due to Manufacturing Defect

    Smiths Medical is recalling 1,000 units of medex TranStar DPT pressure transducers that may monitor inaccurately or interrupt monitoring due to a manufacturing defect. Users may be unable to zero the device.

    Product
    medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0204-2025·2024-10-30

    Medex TranStar pressure monitoring sets recalled due to manufacturing defect

    Smiths Medical is recalling 1,640 units of medex TranStar pressure monitoring sets due to manufacturing defects in the pressure transducer that can cause inaccurate pressure readings or monitoring interruptions.

    Product
    medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0205-2025·2024-10-30

    Smiths Medical SurgiVet pressure transducer recalled for monitoring failures

    Smiths Medical is recalling SurgiVet Advisor Tech Accessories due to manufacturing defects in the pressure transducer that may cause inaccurate, interrupted, or failed pressure monitoring.

    Product
    smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0200-2025·2024-10-30

    Medex TranStar Kids blood sample kit recalled for pressure monitoring failures

    Smiths Medical is recalling approximately 3,280 medex TranStar KIDS KIT blood sample devices due to a manufacturing defect causing pressure monitoring failures.

    Product
    medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0017-2025·2024-10-30

    Smiths Medical CADD Medication Cassette Recalled for Weld Defect Risk

    Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to a weakened weld joint between the medication bag and tubing, which could result in medication leakage. No injuries have been reported.

    Product
    ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0182-2025·2024-10-30

    medex TranStar Pressure Transducer Recall Due to Manufacturing Defect

    Smiths Medical recalls medex TranStar surgical pressure transducers worldwide due to manufacturing defects that may cause inaccurate or interrupted pressure monitoring.

    Product
    medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0184-2025·2024-10-30

    Smiths Medical Recalls 50 medex NICU Monitoring Kits Due to Defect

    Smiths Medical ASD, Inc. is recalling 50 medex NICU Monitoring Kits due to a manufacturing defect that may cause inaccurate pressure monitoring.

    Product
    medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0195-2025·2024-10-30

    Medex TranStar Pressure Transducer Recalled Due to Manufacturing Defect

    Smiths Medical is recalling 1110 units of the medex TranStar DPT pressure transducer due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip failure within the device.

    Product
    medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0143-2025·2024-10-30

    Smiths Medical Portex Nasopharyngeal Airway recalled for sterile packaging seal integrity uncertainty

    Smiths Medical ASD Inc. is recalling 251,591 Portex Nasopharyngeal Airway units worldwide due to uncertainty in sterile packaging seal integrity, potentially compromising the sterile barrier.

    Product
    smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0147-2025·2024-10-30

    Smiths Medical Portex Thermovent 1200 Recalled for Sterile Packaging Seal Issues

    Smiths Medical ASD Inc. is recalling the Thermovent 1200 medical device due to uncertainty in sterile packaging seal integrity. Approximately 141,196 units distributed worldwide are affected.

    Product
    smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0144-2025·2024-10-30

    Smiths Medical Recalls 15mm Double Swivel Connectors Due to Packaging Concerns

    Smiths Medical is recalling 34,141 units of 15mm Double Swivel Connectors worldwide due to uncertainty in the seal integrity of the sterile packaging.

    Product
    smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3090-2024·2024-10-02

    ParaPAC Plus 310 ventilator connector may detach and stop ventilation

    Smiths Medical is recalling paraPAC Plus 310 ventilators because the patient outlet connector may loosen or detach, potentially interrupting ventilation. Approximately 11,244 units worldwide are affected.

    Product
    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3091-2024·2024-10-02

    Smiths Medical Recalls paraPAC 300 Ventilator Kits Due to Connector Issue

    Smiths Medical is recalling 3,182 paraPAC 300 ventilator kits because the patient outlet connector may loosen or detach, impacting active ventilation.

    Product
    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3087-2024·2024-09-18

    Smiths Medical Tracheotomy Tube Kits Recalled for Pilot Balloon Disconnection

    Smiths Medical is recalling approximately 12,234 BLUselect, BLUgriggs, and BLUperc tracheotomy tube kits due to a manufacturing defect that may cause the pilot balloon to disconnect from the inflation line.

    Product
    smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2)…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3086-2024·2024-09-18

    Smiths Medical Tracheostomy Tubes Recalled Due to Pilot Balloon Disconnection Risk

    Smiths Medical is recalling select BLUSelect tracheostomy tubes due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line. No injuries have been reported.

    Product
    smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ; 3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3088-2024·2024-09-18

    Smiths Medical BLUperc tracheostomy tubes recalled for pilot balloon disconnection

    Smiths Medical is recalling BLUperc and BLUselect tracheostomy tube kits worldwide due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line, potentially compromising airway management.

    Product
    smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070; 2) BLUperc…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2974-2024·2024-09-18

    Pneupac ventilator control knob may shift unintentionally during operation

    Smiths Medical ASD Inc. is recalling 10,240 Pneupac paraPAC plus 310 ventilator kits due to risk of unintended tidal volume knob movement, affecting all serial numbers worldwide.

    Product
    Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2611-2024·2024-09-04

    Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Flange Defect

    Smiths Medical is recalling specific lots of Bivona tracheostomy tubes because the securement flange may tear due to a manufacturing defect.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45…
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2606-2024·2024-09-04

    Smiths Medical Bivona Neonatal Tracheostomy Tubes Recalled for Flange Tear

    Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to manufacturing defect that may cause securement flange to tear, compromising tube stability.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code…
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2592-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tubes Recalled for Flange Tearing Defect

    Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, risking loss of airway securement.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2607-2024·2024-09-04

    Bivona Neonatal Tracheostomy Tubes recalled due to defective securement flanges

    Smiths Medical recalls specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes due to manufacturing defects in the securement flange that may tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2614-2024·2024-09-04

    Pediatric Tracheostomy Tubes Recalled Due to Defective Securement Flange

    Smiths Medical recalls pediatric tracheostomy tubes from specific lots due to a manufacturing defect that may cause the securement flange to tear. No injuries have been reported.

    Product
    a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND…
    Category
    Medical Device
    Distribution
    0 states