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.

76–89 of 89

  • CriticalFDA (Devices)·Z-1275-2016·2016-04-13

    FDA Recalls Guardian II Hemostasis Valves Due to Air Embolism Risk

    Vascular Solutions is recalling Guardian II Hemostasis Valves because the low-pressure seal may fail, potentially allowing air into the device and causing an air embolism.

    Product
    Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0156-2015·2014-11-12

    Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect

    Terumo is recalling specific Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.

    Product
    Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2015·2014-11-12

    Terumo Custom Cardioplegia Delivery Sets Recalled for Luer Connector Seal Defect

    Terumo is recalling 24 units of Custom Cardioplegia Delivery Sets because a luer connector defect may compromise the seal and introduce air into the line.

    Product
    Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2015·2014-11-12

    Terumo Cardioplegia Delivery Set Line Recalled for Luer Connector Defect

    Terumo is recalling 165 units of a cardioplegia delivery set line because a luer connector defect can compromise the seal and introduce air into the line.

    Product
    Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2015·2014-11-12

    Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect

    Terumo is recalling 777 Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.

    Product
    Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2015·2014-11-12

    Terumo Custom Cardioplegia Delivery Set Recalled for Luer Connector Defect

    Terumo is recalling Custom Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.

    Product
    Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0955-2013·2013-03-27

    Vascular Solutions Recalls Guardian II Hemostasis Valves Due to Air Embolism Risk

    Vascular Solutions, Inc. is recalling Guardian II and Guardian II NC Hemostasis Valves used in cardiopulmonary bypass because air may be introduced into the device, potentially leading to an air embolism.

    Product
    Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Ze
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0795-2013·2013-02-20

    Lumenis Recalls VersaCut Tissue Morcellator for Labeling Corrections

    Lumenis Limited is recalling VersaCut Tissue Morcellator devices to correct labeling following three reported air embolism events caused by incorrect tubing hook-up.

    Product
    The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0111-2013·2012-10-31

    Ethicon Recalls EVICEL Fibrin Sealant Pressure Regulators Due to Embolism Reports

    Ethicon is recalling EVICEL Fibrin Sealant pressure regulators after reports of air or gas embolism associated with the use of spray devices.

    Product
    EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2013·2012-10-31

    Sorin Gish Reducer Connectors Recalled for Potential Fluid Leakage

    Sorin Group USA is recalling specific lots of Gish Reducer Connectors due to a molding defect that may cause fluid leaks or air entrainment.

    Product
    Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting flex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2013·2012-10-31

    Sorin Gish Straight Connectors Recalled for Potential Fluid Leakage

    Sorin Group USA is recalling specific lots of Gish straight connectors due to a molding defect that may cause fluid leaks or air entrainment.

    Product
    Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting flexible tubing used in extracorpore
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2013·2012-10-17

    Baxter Recalls Clearlink System Buretrol Solution Sets Due to Valve Malfunction

    Baxter Healthcare is recalling 488,504 units of Clearlink System Buretrol Solution Sets because the ball-valve feature may allow air to enter the tubing.

    Product
    Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device Product Usage: The device is used for the administration of fluids from a container into the patient's vascular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalCPSC·96063·1996-01-24

    Trelleborg Viking Recalls Scuba Diving Dry Suit Air Inlet Hose Assemblies

    Trelleborg Viking is recalling approximately 5,000 Viking Sport Dry Suit Air Inlet Hose Assemblies because improper seating can cause a free-flow of air, potentially leading to death or serious injury.

    Product
    Viking Sport Dry Suit Air Inlet Hose Assemblies scuba diving equipment
    Category
    Consumer Product
    Distribution
    Distributed nationwide