The Recall Desk

Hazard

Air Embolism recalls

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

What the numbers show

Total
89
Critical
15
Severe
29
Most recent
2026-07-29

Of the 89 air embolism recalls we have scored against our rubric, 15 (17%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 29 (33%) 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 air embolism 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 89

  • SevereFDA (Devices)·Z-2756-2026·2026-07-29

    Boston Scientific Steerable Sheath Recalled Due to Potential Air Embolism Risk

    Boston Scientific is recalling FARADRIVE STEERABLE SHEATH (CLEAR) because improper dilator insertion can damage the hemostatic valve, potentially leading to air ingress and air embolism.

    Product
    FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2755-2026·2026-07-29

    FARADRIVE STEERABLE SHEATH CLEAR Medical Device Recall

    Boston Scientific recalls FARADRIVE STEERABLE SHEATH CLEAR due to valve damage risk that could cause air embolism during heart procedures.

    Product
    FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2754-2026·2026-07-29

    FARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk

    Boston Scientific recalls 400 units of a cardiac catheter sheath due to potential air embolism risk from valve damage during preparation.

    Product
    FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2757-2026·2026-07-29

    Boston Scientific Steerable Sheath Recall Over Hemostatic Valve Damage

    Boston Scientific is recalling its Faradrive Steerable Sheath devices due to potential hemostatic valve damage during preparation, which may cause air ingress and patient harm.

    Product
    FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2066-2026·2026-05-20

    Medical Angiographic Control Syringes Recalled for Rotating Adapter Risk

    Windstone Medical Packaging is recalling Custom Convenience Kits containing Medline Namic Angiographic Control Syringes due to risk that the rotating adapter may unwind during use, potentially causing disconnection and exposure to biohazards, blood loss, infection, or air embolism.

    Product
    Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1799-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled Due to Potential Air Bubble Accumulation

    B. Braun Medical Inc is recalling STREAMLINE BLOODLINE SET FOR DIALOG (Model Number: SL-2010M2096) because air bubbles may accumulate in the arterial line.

    Product
    B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2026·2026-02-25

    Medline Industries IV Administration and Extension Sets Recalled Due to Potential Leaks

    Medline Industries, LP is recalling various IV administration and extension sets because male luer connectors may leak, crack, or break during use.

    Product
    Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-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-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-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-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-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-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-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
  • SevereFDA (Devices)·Z-1644-2025·2025-04-30

    Amplatzer TorqVue LP Catheter Recalled for Shaft Breach Risk

    Abbott is recalling the Amplatzer TorqVue LP Catheter (Model 9-TVLPC4F90/080) due to a potential small breach in the proximal shaft that may not be visible and could lead to prolonged procedures, blood loss, or air embolism.

    Product
    Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1643-2025·2025-04-30

    Amplatzer TorqVue LP Delivery System Recall for Shaft Breach

    Abbott is recalling specific lots of the Amplatzer TorqVue LP Delivery System due to a possible small breach in the shaft that is not visible but could lead to prolonged procedures, blood loss, or air embolism.

    Product
    Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1507-2025·2025-04-23

    BD 4 Fr Single-Lumen PowerPICC Catheters Recall Risk of Leaks

    Bard Access Systems is recalling BD 4 Fr Single-Lumen PowerPICC Catheters worldwide because tubing material may exceed specifications, causing leaks and potentially serious complications including infection and air embolism.

    Product
    BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2025·2025-01-01

    Abbott Vascular Inflation Device May Leak During Cardiovascular Procedures

    Abbott Vascular is recalling the 20/30 Priority Pack Accessory Kit w/Copilot inflation device used in cardiovascular procedures because it may leak at connection points, potentially causing air embolism.

    Product
    20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0730-2025·2025-01-01

    Abbott 20/30 Indeflator devices recalled for potential leak risk

    Abbott Vascular is recalling 20/30 Indeflator devices used in cardiovascular procedures due to potential leaks that could cause air embolism.

    Product
    20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0731-2025·2025-01-01

    Abbott Vascular inflation device may leak during cardiovascular procedures

    Abbott Vascular is recalling 20/30 Priority Pack Accessory Kit inflation devices due to potential leaks that could cause air embolism during cardiovascular procedures.

    Product
    20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
    Category
    Medical Device
    Distribution
    40 states