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.

676–700 of 717

  • HighFDA (Devices)·Z-0736-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain tubing may leak or disconnect

    Atrium Medical Corporation is recalling 624 units of Ocean Water Seal Chest Drain ATS Blood Recovery Systems because the tubing may leak or disconnect.

    Product
    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0738-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recalled

    Atrium Medical Corporation is recalling 361 units of the Ocean Water Seal Chest Drain ATS Blood Recovery System because the tubing may leak or disconnect.

    Product
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Code: 2052-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0679-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

    Product
    8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0661-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave ¿, NanoClave¿ T-Connector, Rotating Luer, Part No. A1000, Item No. 011-A1094 The ICU Needleless Connector is a single use, sterile, non-pyro
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0684-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. K7090-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular a
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0676-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave¿, Rotating Luer, Part No. A1000, Item No. A1080 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the admin
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0664-2014·2014-01-15

    ICU Medical Recalls NanoClave Stopcock Due to Potential Leakage

    ICU Medical is recalling specific lots of NanoClave Stopcocks because a small percentage of the devices may leak.

    Product
    NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the v
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0706-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoClave¿ T-Connector, Rotating Luer, Item # A1003, Lot # 2773812. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administrat
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0695-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the adm
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0672-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the adminis
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0705-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Leakage Risk

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0699-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Leakage Risk

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    120" 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 2 Ext, Part No. A1000, Item No. SC125 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accesso
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0707-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lot # 2796668. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0424-2014·2013-12-04

    B. Braun addEASE Binary Connector Recalled for Possible Solution Leakage

    B. Braun Medical is recalling addEASE Binary Connectors because a misaligned needle may cause solution to leak from the PAB bag.

    Product
    20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0022-2014·2013-10-23

    Harvest Graft Delivery System Recalled for Potential Luer Connector Leaks

    Harvest Technologies is recalling 730 cases of the Harvest Graft Delivery System because the Luer connector may leak or crack.

    Product
    Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-831-2013·2013-08-07

    Baxter Recalls DIANEAL Low Calcium Peritoneal Dialysis Solution Due to Container Defect

    Baxter Healthcare is recalling 39,486 containers of DIANEAL Low Calcium with Dextrose peritoneal dialysis solution because defective containers may leak when the closure is removed.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1765-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Surface Leakage

    LeMaitre Vascular is recalling 2 units of AlboGraft Woven with Collagen, Straight 15x26 (Lot 56890A) because blood blushing or leaking was observed from the graft surface after implantation.

    Product
    AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1679-2013·2013-07-17

    Baxter Elastomeric Infusion Pumps Recalled for Leakage at Luer Connection

    Baxter Healthcare is recalling specific lots of elastomeric infusion pumps due to reported leakage at the blue winged cap connection after storage.

    Product
    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for sl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2013·2013-07-17

    Baxter Elastomeric Infusion Pumps Recalled for Leakage at Luer Connection

    Baxter Healthcare is recalling specific lots of elastomeric infusion pumps due to reported leakage at the blue winged cap and distal male Luer connection after storage.

    Product
    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for sl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2013·2013-07-17

    Baxter Elastomeric Infusion Pumps Recalled for Leakage at Luer Connection

    Baxter Healthcare is recalling specific lots of elastomeric infusion pumps due to reported leakage at the blue winged cap and distal male Luer connection.

    Product
    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for sl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1674-2013·2013-07-17

    Fresenius Liberty Cycler Set Recalled for Potential Leakage During Dialysis

    Fresenius Medical Care is recalling 5,480 units of the Liberty Cycler Set due to a risk of cassette leakage during setup or treatment.

    Product
    Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-627-2013·2013-07-10

    Baxter Recalls Lidocaine Injection Due to Sterility Concerns

    Baxter Healthcare is recalling specific lots of Lidocaine Hydrochloride and 5% Dextrose Injection due to a manufacturing defect that may compromise sterility.

    Product
    Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-625-2013·2013-07-10

    Baxter Recalls 5% Dextrose Injection Due to Sterility Concerns

    Baxter Healthcare is recalling specific lots of 5% Dextrose Injection due to a manufacturing defect that may compromise sterility.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-608-2013·2013-06-26

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Hospira is recalling 676,872 containers of 0.9% Sodium Chloride Injection due to a potential leak at the administrative port that compromises sterility.

    Product
    0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1099-2013·2013-04-17

    US Endoscopy Recalls Torrent Irrigation Tubing Due to Water Leakage

    US Endoscopy Group Inc is recalling Torrent irrigation tubing because customers reported water leakage from the white tubing connector.

    Product
    Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic proc
    Category
    Medical Device
    Distribution
    Distributed nationwide