Smiths Medical ASD, Inc.: 173 recalls on record

Recalls filed with 1 agency: FDA (173).

First recall on record: July 18, 2012. Most recent: May 14, 2025.

Risk classification: Class I: 56 · Class II: 112 · Class III: 5

Most recent recalls

DateAgencyProduct
September 18, 2024FDAPneupac paraPAC plus 300 ventilator kit, REF P300NXXZ-2973-2024
September 18, 2024FDAsmiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tra…Z-3087-2024
September 18, 2024FDAPneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXXZ-2974-2024
September 18, 2024FDAsmiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.…Z-3086-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS…Z-2598-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOS…Z-2605-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM…Z-2599-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product…Z-2591-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2…Z-2613-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM T…Z-2588-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , …Z-2590-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT T…Z-2594-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.…Z-2592-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.…Z-2609-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM…Z-2596-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM…Z-2604-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Pro…Z-2606-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4…Z-2612-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND…Z-2593-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM…Z-2595-2024
September 4, 2024FDAa) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Numbe…Z-2614-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Pr…Z-2610-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE …Z-2611-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEO…Z-2602-2024
September 4, 2024FDAPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MI…Z-2589-2024

Questions about this company

How many recalls does Smiths Medical ASD, Inc. have?
Recalert has 173 U.S. recalls on record for Smiths Medical ASD, Inc., published between July 18, 2012 and May 14, 2025.
Which agencies have handled Smiths Medical ASD, Inc. recalls?
Smiths Medical ASD, Inc. appears as the recalling firm in recalls from: FDA (173).

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