The Recall Desk

Hazard

Leak recalls

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

What the numbers show

Total
493
Critical
3
Severe
28
Most recent
2026-08-26

Of the 493 leak recalls we have scored against our rubric, 3 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 28 (6%) 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 leak 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.

176–200 of 493

  • HighFDA (Devices)·Z-0945-2019·2019-03-06

    Arrow AutoFuser Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling specific AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Leaks

    Arrow International is recalling specific AutoFuser pumps due to possible cracks in the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0948-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling specific AutoFuser pumps due to possible cracks in the fill port connector that could cause leaks and reduced drug delivery.

    Product
    AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling 26 units of the AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks.

    Product
    AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0955-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International Inc. is recalling Arrow AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Leaks

    Arrow International Inc. is recalling Arrow AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling 19 units of the AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling 8 units of the AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks.

    Product
    AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0710-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking

    Smiths Medical is recalling Portex 350 ml Sterile Water Humidifiers because leaking containers may expose patients to infectious agents.

    Product
    Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0717-2019·2019-02-13

    Medline Sterile Water Humidifier Recalled for Leaking Containers

    Smiths Medical is recalling Medline sterile water humidifiers because leaking containers may expose patients to infectious agents.

    Product
    Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0716-2019·2019-02-13

    Smiths Medical Recalls Intermed 550 ml Sterile Water Humidifiers

    Smiths Medical is recalling Intermed 550 ml Sterile Water Humidifiers due to leaking containers that may compromise sterility and expose patients to infectious agents.

    Product
    Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0512-2019·2018-12-05

    Smiths Medical Recalls Medex High Pressure Stopcocks Due to Leak Risk

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Stopcocks because an inner body defect may cause the device to leak.

    Product
    Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2799-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2811-2018·2018-08-22

    ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold connection.

    Product
    61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2815-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2801-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2809-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2812-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2813-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2798-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2808-2018·2018-08-22

    ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of 150 pouches of smallbore I.V. administration sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2803-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and manifold.

    Product
    18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2802-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall for I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states