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.

26–50 of 89

  • SevereFDA (Devices)·Z-0094-2024·2023-10-25

    Sapphire Infusion Pumps recalled for software air-detection failure

    Sapphire Infusion Pumps with software revisions 16.10.1 or 16.10.2 may fail to detect air in the infusion line, potentially causing life-threatening air embolism. Approximately 1,383 units have been distributed nationwide.

    Product
    Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2110-2023·2023-07-19

    Abbott Cardiac Catheter Sheath Recalled Due to Air Embolism Risk

    Abbott is recalling the Amplatzer Steerable Delivery Sheath (ASDS), a cardiac catheter, due to a 0.77% reported incidence rate of air embolism during procedures. The recalled 675 units are distributed worldwide.

    Product
    Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2023·2023-03-08

    Vascular diagnostic device recalled for air line misconnection risk

    Unetixs Vascular is recalling the MultiLab Series II REVO vascular diagnostic device because faulty connectors may allow the air line to be misconnected to an IV line, potentially causing a dangerous air embolism.

    Product
    MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1193-2023·2023-03-08

    Medical Device Recall: Vascular Diagnostic Device Air Embolism Risk

    Unetixs Vascular is recalling 1706 units of the MultiLab Series II 2CP & 2CP Express vascular diagnostic device due to luer fittings that could allow air lines to be misconnected to intravenous lines, potentially causing air embolism.

    Product
    MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2023·2023-03-08

    Vascular diagnostic devices recalled due to air embolism misconnection risk

    Unetixs Vascular recalls MultiLab Series II vascular diagnostic devices worldwide due to a design flaw where air lines can be misconnected to IV lines, potentially causing air embolism.

    Product
    MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1195-2023·2023-03-08

    Vascular Diagnostic Device Recalled for Risk of Air Line Misconnection

    Unetixs Vascular recalls MultiLab Series II ROODRA vascular diagnostic devices due to luer fittings that may allow air line misconnection to intravenous lines, potentially causing air embolism.

    Product
    MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2023·2022-10-26

    ULTRASITE US04TL Extension Sets recalled for bonded joint failure risk

    B. Braun is recalling ULTRASITE Extension Sets because the bonded joint has a high probability of failure during use. Device failure could cause leakage, bloodstream infections, and delays in therapy.

    Product
    ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2285-2021·2021-09-01

    Monoject Sodium Chloride Flush Syringes Recalled for Air Embolism Risk

    Cardinal Health recalls 267 million Monoject 0.9% Sodium Chloride Flush Syringes due to a plunger defect that may reintroduce air into the syringe, posing a risk of air embolism during IV administration.

    Product
    Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2021·2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 100 units of DiamondTemp Unidirectional Small Curve Ablation Catheters because packaging and instructions list incorrect catheter sizes, posing a risk of blood clots or air emboli.

    Product
    EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1322-2021·2021-04-07

    EPIX Therapeutics DiamondTemp Catheter Recalled for Labeling Errors

    EPIX Therapeutics is recalling 13 DiamondTemp Unidirectional Ablation Catheters because packaging and instructions list incorrect sizes, posing a risk of blood clots or air emboli.

    Product
    EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1319-2021·2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 15 DiamondTemp Bidirectional Small Curve Ablation Catheters because the packaging and instructions for use list incorrect catheter sizes.

    Product
    EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2665-2020·2020-07-29

    Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks

    Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack, risking leakage of chemicals or blood.

    Product
    SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2664-2020·2020-07-29

    Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks

    Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, risking leakage of chemicals or blood.

    Product
    SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN162075 (UDI 00801741119675), AN162075G (UDI 00801741119439)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2667-2020·2020-07-29

    Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks

    Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack, risking chemical exposure, blood loss, or infection.

    Product
    SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2660-2020·2020-07-29

    Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks

    Becton Dickinson is recalling PowerLoc MAX infusion sets because tubing cracks may cause leakage of chemicals or biohazard materials.

    Product
    PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2668-2020·2020-07-29

    Becton Dickinson SafeStep Huber Needle Set Recall for Tubing Cracks

    Becton Dickinson is recalling SafeStep Huber Needle Sets with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kits due to potential tubing cracks that may cause leakage.

    Product
    SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2663-2020·2020-07-29

    Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks

    Becton Dickinson is recalling PowerLoc MAX infusion sets because tubing may crack, risking leakage of chemicals or biohazard materials.

    Product
    PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2670-2020·2020-07-29

    Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks

    Becton Dickinson is recalling PowerLoc MAX Power Injectable Infusion Sets because tubing may crack or break near the Luer or Y site, risking leakage of chemicals or blood.

    Product
    PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2671-2020·2020-07-29

    Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks

    Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, potentially causing leakage of chemicals or biohazard materials.

    Product
    SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI 00801741066184), LH-0031 (UDI 00801741066207), LH-0032 (UDI 00801741066221), LH-0033 (UDI 00801741066245), LH-0034 (UDI 00801741066269), LH-0035 (UDI 00801741066283), LH-0036 (UDI 0080174106630
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2662-2020·2020-07-29

    Becton Dickinson Recalls PowerLoc MAX Infusion Port Access Kits

    Becton Dickinson is recalling PowerLoc MAX Power Injectable Infusion Port Access Kits due to potential tubing cracks that may cause leakage of hazardous materials.

    Product
    PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 (UDI 00801741044199), 2132075 (UDI 00801741044205), 2132210 (UDI 00801741044212)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2669-2020·2020-07-29

    Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks

    Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, potentially causing leakage of hazardous chemicals or blood.

    Product
    SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (UDI 00801741066177), LH-0030YN (UDI 00801741066191), LH-0031YN (UDI 00801741066214), LH-0032YN (UDI 00801741066238), LH-0033YN (UDI 00801741066252), LH-0034YN (UDI 008
    Category
    Medical Device
    Distribution
    0 states