The Recall Desk

Hazard

Airway Compromise recalls

56 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
56
Critical
2
Severe
17
Most recent
2024-09-04

Of the 56 airway compromise recalls we have scored against our rubric, 2 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 17 (30%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all airway compromise recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 56

  • 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-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-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
  • HighFDA (Devices)·Z-1308-2024·2024-03-27

    Curaplex Nasal Intubation Kit with incompatible tube holder recalled

    Sarnova HC is recalling the Curaplex Nasal Intubation Kit because the endotracheal tube holder is incompatible with nasal intubation, preventing practitioners from securing the tube. The recall affects 550 units distributed nationwide.

    Product
    Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2024·2024-01-24

    Curaplex Cricothyrotomy Field Kit Recalled for Incompatible Tube Holder

    Sarnova HC recalls 15 Curaplex Cricothyrotomy Field Kits nationwide due to an incompatible endotracheal tube holder that prevents proper tube securement during cricothyrotomy procedures.

    Product
    Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1893-2023·2023-07-05

    Teleflex Endotracheal Tubes Recalled Due to Connector Disconnection Risk

    Teleflex is recalling 18,620 endotracheal tubes due to reported disconnection of 15mm connectors. The tubes are used for oral and nasal intubation and were distributed nationwide.

    Product
    Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1881-2023·2023-07-05

    Endotracheal Tubes Recalled for 15mm Connector Disconnection

    TELEFLEX LLC recalls 2,520 endotracheal tubes (model REF 112080055) due to reports of 15mm connector disconnection. The disconnection could compromise airway function during critical care use.

    Product
    Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1860-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Recall

    TELEFLEX LLC is recalling Slick Set Cuffed Endotracheal Tubes (REF 1700100) due to reports of the 15mm connector disconnecting from the device during use.

    Product
    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1953-2023·2023-07-05

    Endotracheal Tubes Recalled for Potential 15mm Connector Disconnection

    TELEFLEX LLC is recalling Preformed AGT Oral Endotracheal Tubes because the 15mm connector may disconnect from the tube, creating a potential airway access risk.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1900-2023·2023-07-05

    FDA Recalls Slick Set Uncuffed Endotracheal Tubes for Connector Disconnection

    Teleflex is recalling approximately 2,550 Slick Set Uncuffed Endotracheal Tubes (REF 150020) due to reports of 15mm connector disconnection.

    Product
    Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1945-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Recall: TELEFLEX Preformed AGT

    TELEFLEX is recalling 16,570 units of Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection, which could compromise airway management during use.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1943-2023·2023-07-05

    Oral Endotracheal Tubes Recalled for 15mm Connector Disconnection Risk

    Teleflex LLC is recalling 19,842 preformed oral endotracheal tubes due to reports of 15mm connector disconnection. Affected devices were distributed nationwide.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1895-2023·2023-07-05

    RUSCHELIT Safety Clear Tracheal Tubes recalled for connector disconnection risk

    Teleflex is recalling RUSCHELIT Safety Clear Tracheal Tubes due to reports of 15mm connector disconnection. The affected tubes are distributed nationwide.

    Product
    RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1950-2023·2023-07-05

    Endotracheal Tube Connector May Disconnect During Patient Use

    Teleflex recalls preformed AGT oral endotracheal tubes because the 15mm connector may disconnect from the tube, posing risk during patient use.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1870-2023·2023-07-05

    Preformed AGT Oral Endotracheal Tubes recalled for connector disconnection risk

    TELEFLEX is recalling 2,874 Preformed AGT Oral Endotracheal Tubes nationwide due to reports of the 15mm connector disconnecting from the tube. Affected users should immediately discontinue use.

    Product
    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1894-2023·2023-07-05

    Endotracheal tubes recalled for 15mm connector disconnection

    Teleflex is recalling 19,250 endotracheal tubes because the 15mm connector may disconnect during use, potentially compromising airway management in patients.

    Product
    Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1925-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Reported by Teleflex

    Teleflex is recalling endotracheal tubes due to reports of disconnection between the tube and its 15mm connector. Affected devices were distributed nationwide including Puerto Rico.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1939-2023·2023-07-05

    Endotracheal Tubes Recalled for Connector Disconnection by Teleflex

    TELEFLEX LLC is recalling 2,140 endotracheal tubes nationwide due to reports of the 15mm connector disconnecting from the tube. Affected units were distributed throughout the United States, including Puerto Rico.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1885-2023·2023-07-05

    Teleflex endotracheal tubes recalled due to connector disconnection

    Teleflex has recalled 49,050 endotracheal tubes due to reported disconnection of the 15mm connector. Affected units were distributed nationwide, including Puerto Rico.

    Product
    Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2023·2023-04-05

    Covidien Shiley Lo-Pro Tracheal Tube Cuffed Recalled for Potential Inflation System Leaks

    Covidien is recalling Shiley Lo-Pro Oral/Nasal Tracheal Tubes due to potential leaks in the inflation system. The affected devices, used during anesthesia and procedures, may not maintain proper airway sealing.

    Product
    COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or other short-term procedures.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1420-2022·2022-07-27

    Ambu VivaSight 2 DLT endobronchial tubes recalled for cuff leak risk

    Ambu Inc. is recalling the VivaSight 2 DLT endobronchial tube system due to reports of cuff leaks or ruptures that could compromise airway security during intubation procedures.

    Product
    Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2022·2022-04-20

    Medline Laryngeal Masks recalled due to potential cuff disconnection

    Medline Industries is recalling approximately 8,990 cases of Standard PVC Laryngeal Masks distributed nationwide because the mask cuff may disconnect from the breathing tube.

    Product
    Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1759-2019·2019-06-26

    Teleflex Recalls Sheridan LTS Tracheal Tubes Due to Connector Disconnection

    Teleflex Medical is voluntarily recalling specific lots of Sheridan LTS tracheal tubes because the 15 mm connector may disconnect from the tube.

    Product
    Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1766-2019·2019-06-26

    Teleflex Recalls Sheridan Novaplus Endotracheal Tubes Due to Connector Disconnection

    Teleflex Medical is voluntarily recalling specific lots of Sheridan Novaplus endotracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.

    Product
    Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tracheal tube/airway management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1760-2019·2019-06-26

    Teleflex Medical Recalls Hudson RCI Sheridan Tracheal Tubes

    Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm Sheridan connector may become disconnected from the endotracheal tube.

    Product
    Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116
    Category
    Medical Device
    Distribution
    Distributed nationwide