The Recall Desk

Hazard

Ventilation recalls

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

What the numbers show

Total
16
Critical
15
Severe
0
Most recent
2025-12-17

Of the 16 ventilation recalls we have scored against our rubric, 15 (94%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all ventilation 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.

1–16 of 16

  • CriticalFDA (Food)·H-0252-2026·2025-12-17

    ErgoStar CM 40 airway connectors recalled after cracks formed in the hose

    Draeger is recalling 14,420 ErgoStar CM 40 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.

    Product
    Deep-brand Premium Select Chikoo Slices KEEP FROZEN Net Wt. 12 oz. (340 g)
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0591-2026·2025-12-17

    Ventilator airway connectors recalled after cracks formed in the hose

    Draeger is recalling 191,470 ErgoStar CM 45 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.

    Product
    ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
    Category
    Medical Device
    Distribution
    10 states
  • CriticalFDA (Devices)·Z-0593-2026·2025-12-17

    ErgoStar CM 60 airway connectors recalled after cracks formed in the hose

    Draeger is recalling 2,050 ErgoStar CM 60 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.

    Product
    ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
    Category
    Medical Device
    Distribution
    10 states
  • CriticalFDA (Devices)·Z-0592-2026·2025-12-17

    ErgoStar CM 55 airway connectors recalled after cracks formed in the hose

    Draeger is recalling 118,850 ErgoStar CM 55 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.

    Product
    ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
    Category
    Medical Device
    Distribution
    10 states
  • CriticalFDA (Devices)·Z-2434-2025·2025-09-10

    FXD Curve single access systems recalled over air embolism likelihood

    Boston Scientific is recalling WATCHMAN FXD Curve Access System Sgl after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2429-2025·2025-09-10

    FXD Curve access systems recalled over air embolism risk during transseptal procedures

    Boston Scientific is recalling WATCHMAN FXD Curve Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2427-2025·2025-09-10

    TruSeal double access systems recalled over air embolism risk under sedation

    Boston Scientific is recalling WATCHMAN TruSeal Access System DBL after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2426-2025·2025-09-10

    TruSeal single access systems recalled over transseptal air ingress risk

    Boston Scientific is recalling WATCHMAN TruSeal Access System SGL, OUS, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2431-2025·2025-09-10

    WATCHMAN TruSeal access systems recalled over air embolism during transseptal access

    Boston Scientific is recalling WATCHMAN TruSeal Access System SGL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2435-2025·2025-09-10

    FXD Curve double access systems recalled over transseptal air embolism risk

    Boston Scientific is recalling WATCHMAN FXD Curve Access System Dbl after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2432-2025·2025-09-10

    TruSeal DBL access systems recalled over air embolism risk without ventilation

    Boston Scientific is recalling WATCHMAN TruSeal Access System DBL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2433-2025·2025-09-10

    TruSeal ANT access systems recalled over air embolism risk without controlled ventilation

    Boston Scientific is recalling WATCHMAN TruSeal Access System ANT after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2428-2025·2025-09-10

    Transseptal access systems recalled over higher air embolism risk without controlled ventilation

    Boston Scientific is recalling WATCHMAN TruSeal Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation. 340,185 units are affected.

    Product
    WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2436-2025·2025-09-10

    TruSteer transseptal access systems recalled over higher air embolism risk

    Boston Scientific is recalling WATCHMAN TruSteer Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2430-2025·2025-09-10

    FXD Curve access systems recalled over ventilation-related air embolism risk

    Boston Scientific is recalling WATCHMAN FXD Curve Access Sys Dbl after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states