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.

76–100 of 293

  • SevereFDA (Devices)·Z-2589-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled Due to Securement Flange Tear Risk

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because a manufacturing defect may cause the securement flange to tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Produc
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2594-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tubes Recalled Due to Flange Tearing Defect

    PORTEX Bivona Tracheostomy Tubes (3.0mm, 3.5mm, 4.0mm) are being recalled due to a manufacturing defect that may cause the securement flange to tear. This could result in airway obstruction or loss of tube securement.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH T
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2599-2024·2024-09-04

    Tracheostomy Tubes Recalled Due to Securement Flange Tears

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. These tubes are used for neonatal, pediatric, and adult patients worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2602-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tubes Recalled for Defective Securement Flange

    Smiths Medical is recalling PORTEX Bivona neonatal and pediatric tracheostomy tubes worldwide due to a manufacturing defect in the securement flange that may tear and affect proper positioning.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUB
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2598-2024·2024-09-04

    Tracheostomy Tube Flange May Tear Due to Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. This affects pediatric and adult sizes distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2600-2024·2024-09-04

    Tracheostomy Tube Recall: PORTEX Bivona Due to Manufacturing Defect in Securement Flange

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because of a manufacturing defect that may cause the securement flange to tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Product Code/List Number/Item Code 60PFSS25
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2601-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled Due to Defective Securement Flange

    Smiths Medical is recalling PORTEX Bivona Tracheostomy Silicone Tubes because the securement flange may tear due to a manufacturing defect. The defect affects multiple lot numbers across all size variants distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2596-2024·2024-09-04

    Bivona Neonatal, Pediatric, and Adult Tracheostomy Tubes Recalled for Flange Defect

    Smiths Medical is recalling specific lots of Bivona Neonatal, Pediatric, and Adult Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, potentially compromising tube security.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FL
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2612-2024·2024-09-04

    Tracheostomy Tubes Recalled for Possible Flange Tearing Due to Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona pediatric and neonatal tracheostomy tubes because the securement flange may tear due to a manufacturing defect. The recall affects multiple tube sizes distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2588-2024·2024-09-04

    Smiths Medical Bivona Tracheostomy Tubes Recalled for Flange Tear Risk

    Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected lots include neonatal, pediatric, and adult sizes distributed worldwide with 177,340 units impacted.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2609-2024·2024-09-04

    PORTEX Bivona Neonatal Tracheostomy Tubes May Tear Due to Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear, affecting device positioning.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2605-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled for Potential Securement Flange Failure

    Smiths Medical recalled specific lots of Bivona Tracheostomy Tubes after identifying a manufacturing defect that may cause the securement flange to tear, risking tube displacement.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030; 3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE ,
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2615-2024·2024-09-04

    PORTEX Bivona Neonatal and Pediatric Tracheostomy Tubes Recalled for Flange Tear

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

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRAC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2597-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tube Securement Flange May Tear Due to Manufacturing Defect

    Smiths Medical recalls specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, potentially affecting tube positioning.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2613-2024·2024-09-04

    Tracheostomy Tubes Recalled for Torn Securement Flange Risk

    Smiths Medical recalls PORTEX Bivona tracheostomy tubes due to a manufacturing defect that may cause the securement flange to tear, potentially leading to tube dislodgement.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2595-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tubes Recalled for Securement Flange Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. Products distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , P
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2590-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tube Securement Flange May Tear

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. The recall affects neonatal, pediatric, and adult versions distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2604-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled for Manufacturing Defect in Securement Flange

    Smiths Medical recalls specific lots of Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes worldwide due to a manufacturing defect that may cause the securement flange to tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , P
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2603-2024·2024-09-04

    Tracheostomy Tubes Recalled for Manufacturing Defect Affecting Securement Flange

    Smiths Medical recalled specific lots of PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products were distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65
    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
  • HighFDA (Devices)·Z-2593-2024·2024-09-04

    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: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2610-2024·2024-09-04

    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) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (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 STRA
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2421-2024·2024-08-14

    Smiths Medical CADD-Solis VIP Ambulatory Infusion Pumps Recalled Worldwide

    Smiths Medical is recalling CADD-Solis VIP ambulatory infusion pumps (models 21-2120, 21-2125, 21-2127) worldwide. The FDA has classified this as a Class I recall.

    Product
    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies t
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2420-2024·2024-08-14

    CADD-Solis VIP Ambulatory Infusion Pump Class I Recall

    Smiths Medical is recalling CADD-Solis VIP Model 2110 infusion pumps in a Class I action affecting units worldwide.

    Product
    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of in
    Category
    Medical Device
    Distribution
    0 states