The Recall Desk

Hazard

Leakage recalls

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

What the numbers show

Total
717
Critical
4
Severe
166
Most recent
2026-08-26

Of the 717 leakage recalls we have scored against our rubric, 4 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 166 (23%) are Severe.

About this hazard tag

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

251–275 of 717

  • HighFDA (Devices)·Z-1114-2019·2019-04-17

    Vygon DUALSTOP Red Caps Recalled for Defects Causing Leaks

    Vygon U.S.A. is recalling 339,800 DUALSTOP Red Caps used for intravascular lines because a defect causes leaks.

    Product
    Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0803-2019·2019-02-13

    Bard Medical Recalls SureStep Foley Tray System Due to Leakage Risk

    Bard Medical Division is recalling SureStep Foley Tray Systems because urine may leak around the vent on the vented sample port.

    Product
    SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A30491
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0786-2019·2019-02-06

    Medtronic Recalls Suction and Anticoagulation Assemblies Due to Connector Defects

    Medtronic is recalling 7,587 Suction and Anticoagulation Assemblies because Y-connectors may tear or crack, potentially causing leaks and blood loss.

    Product
    SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2019·2019-02-06

    Haemonetics Recalls Cell Saver Elite Processing Kits Due to Leakage Risk

    Haemonetics is recalling 4,576 Cell Saver Elite Processing Kits because the 70ml centrifuge bowl may leak during cell salvage processing.

    Product
    Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a resu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0778-2019·2019-02-06

    Haemonetics Recalls Cell Saver 5/5+ Bowl Sets Due to Leakage

    Haemonetics is recalling 11,208 units of Cell Saver 5/5+ Bowl Sets because the 70ml centrifuge bowls may leak during cell salvage processing.

    Product
    Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0663-2019·2019-01-02

    ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems

    ICU Medical is recalling Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.

    Product
    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0662-2019·2019-01-02

    ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems

    ICU Medical is recalling 1,760 units of Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.

    Product
    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0661-2019·2019-01-02

    ICU Medical Recalls Thermoset Room Temperature Injectate Delivery Systems

    ICU Medical is recalling 27,250 Thermoset Room Temperature Closed Loop Injectate Delivery Systems due to a defect in the thermoset check valve component that may cause leakage.

    Product
    Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
    Category
    Medical Device
    Distribution
    31 states
  • SevereFDA (Drugs)·D-0215-2019·2018-11-14

    ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 5% Dextrose Injection bags because they may lack sterility and have the potential to leak.

    Product
    5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2019·2018-11-14

    Becton Dickinson Recalls PCEA Administration Sets Due to Potential Leaks

    Becton Dickinson is recalling PCEA Administration Sets because they may leak at the connection point. The recall covers 566,737 units distributed worldwide.

    Product
    PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0386-2019·2018-11-14

    Becton Dickinson Recalls PCEA ASV Yellow Microbore Administration Sets

    Becton Dickinson is recalling PCEA ASV Yellow Microbore administration sets because they may leak at the luer lock connection.

    Product
    PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2019·2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 136,800 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2019·2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 158,163 units of Exactamix Empty EVA Bags because they may leak after being used for compounding.

    Product
    EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2019·2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 110,134 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2019·2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 456,071 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0173-2019·2018-10-24

    Life Technologies Recalls Gibco Sodium Pyruvate Due to Leaky Bottle Caps

    Life Technologies is recalling 41 units of Gibco Sodium Pyruvate (100 mM) because defective bottle caps may compromise product sterility.

    Product
    Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2019·2018-10-24

    Life Technologies Recalls Gibco GlutaMAX Supplement Due to Leaky Bottles

    Life Technologies is recalling 1,912 units of Gibco GlutaMAX Supplement because defective bottle caps may compromise the product's sterility.

    Product
    Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0172-2019·2018-10-24

    Life Technologies Recalls Gibco DPBS Due to Leaky Bottle Caps

    Life Technologies is recalling 240 units of Gibco DPBS due to defective bottle caps that compromise sterility.

    Product
    Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3364-2018·2018-10-10

    B. Braun Medical Recalls CE18TB Epidural Trays Due to Leakage

    B. Braun Medical is recalling CE18TB epidural trays because the catheter connectors may not stay closed, causing leakage or disconnection.

    Product
    CE18TB CONT EPIDURAL TRAY, Material Number 332222 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3381-2018·2018-10-10

    B. Braun Medical Recalls Catheter Connectors Due to Leakage and Disconnection

    B. Braun Medical is recalling 6,850 clamp-style catheter connectors because they may not stay closed, causing leakage or disconnection.

    Product
    CLAMP STYLE CATH. CONNECTOR 18-19 GA- LF, Material Number 332285 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3375-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 1,980 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TB19C CONT EPIDURAL TRAY, Material Number 332242 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3321-2018·2018-10-10

    B. Braun Medical Recalls Contiplex Tuohy Sets Due to Leakage

    B. Braun Medical is recalling 1,848 Contiplex Tuohy Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CONTIPLEX TUOHY SET, 18GX11/2X 1,3X40MM, Material Number 331695 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjuncti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3323-2018·2018-10-10

    B. Braun Medical Recalls Contiplex Cont Nerve Block Catheter Connectors

    B. Braun Medical is recalling specific lots of Contiplex Cont Nerve Block catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CNB200TK CONTIPLEX CONT NERVE BLOCK, Material Number 331701 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3342-2018·2018-10-10

    B. Braun Medical Recalls 17 GA Epidural Catheter Connectors

    B. Braun Medical is recalling specific epidural catheter connectors that may not stay closed, leading to potential leakage or disconnection.

    Product
    CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction w
    Category
    Medical Device
    Distribution
    Distributed nationwide