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 (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-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 (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
HighNHTSA·25V681000·2025-10-10
Recreational trailers recalled over waste tank vent pipe releasing sewer gas
Forest River is recalling eight 2026 Flagstaff and Rockwood trailers whose waste water holding tank ventilation pipe may not be terminated outside the vehicle.
Product
FOREST RIVER — FOREST RIVER ROCKWOOD, FLAGSTAFF
Category
Vehicle
Distribution
Distributed nationwide
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-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-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-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-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
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-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