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.

151–175 of 493

  • HighFDA (Devices)·Z-0899-2020·2020-02-05

    Haemonetics Recalls Japan Disp Sets Due to Potential Bowl Cracks

    Haemonetics is recalling specific Japan Disp Sets for Cell Saver systems due to potential bowl cracks that may cause leaks and incomplete blood washing.

    Product
    JAPAN DISP SET, 261J, 205J, 208 - Product Usage: 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 result of trauma. The recovered blood is processed by a centrifugation and washing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0715-2020·2019-12-25

    Arrow Berman Angiographic Catheter Recalled for Potential Leak

    Arrow International Inc. is recalling 71 units of Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.

    Product
    Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0716-2020·2019-12-25

    Arrow Berman Angiographic Catheter Recalled for Potential Balloon Leak

    Arrow International Inc is recalling specific Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.

    Product
    Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0150-2020·2019-10-30

    Nephron Amino Acid Injection Recalled for Sterility and Leak Concerns

    Nephron Pharmaceuticals is recalling 162 bags of Amino Acid Injection due to lack of sterility assurance and potential leaks.

    Product
    Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2020·2019-10-30

    Baxter Recalls EXACTAMIX Empty EVA TPN Bags Due to Leak Risk

    Baxter Healthcare is recalling EXACTAMIX Empty EVA TPN bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the des
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2019·2019-10-02

    B.Braun Infusion Pump Administration Set Recalled for Potential Leaks

    B. Braun Medical is recalling 2,580 Infusomat Space Volumetric Infusion Pump Administration Sets due to a risk of leaking or disconnecting at the Y-site joint.

    Product
    B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2349-2019·2019-08-28

    Thoratec Heartmate 3 Sealed Outflow Graft Recall for Leak Risk

    Thoratec Corp. is recalling 149 Heartmate 3 Sealed Outflow Graft units because the C-Ring may not seat properly, causing leaks during implantation.

    Product
    Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2348-2019·2019-08-28

    Thoratec HeartMate 3 LVAS Implant Kit Recalled for Outflow Graft Leaks

    Thoratec Corp. is recalling HeartMate 3 LVAS Implant Kits because an insufficiently seated C-Ring can cause the outflow graft to leak during implantation, rendering the device nonfunctional.

    Product
    Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2211-2019·2019-08-14

    Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues

    Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction issues, and failure to obtain samples.

    Product
    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 12G - REF ECP0112G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2209-2019·2019-08-14

    Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues

    Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction issues, and failure to obtain samples.

    Product
    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2019·2019-08-14

    Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues

    Bard Peripheral Vascular Inc is recalling 239 units of EnCor Breast Biopsy Probes due to reports of leaks, suction issues, and failure to obtain tissue samples.

    Product
    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (Vertical) - REF ECP0112GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2019·2019-08-14

    Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues

    Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction issues, and failure to obtain samples.

    Product
    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G.Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2099-2019·2019-08-07

    Inovo Single Luman Conserver Recalled for Potential Pressure Gauge Dislodgement

    Inovo, Inc. is recalling 690 Single Luman Conservers because the pressure gauge may dislodge from the mount, creating a leak.

    Product
    Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency and cost saving ratios.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1710-2019·2019-06-12

    BD Nexiva IV Catheter System Recalled for Septum Leak Risk

    Becton Dickinson is recalling 6,720 units of BD Nexiva Dual Port 20GA IV Catheter Systems due to a potential leak that could expose health care workers to blood.

    Product
    BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1115-2019·2019-04-17

    Vygon DUALSTOP White Caps Recalled for Defect Causing Leaks

    Vygon U.S.A. is recalling Vyon DUALSTOP White Caps used for intravascular lines because a defect causes leaks in the affected product.

    Product
    Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2019·2019-04-17

    Edwards IntraClude Intra-Aortic Occlusion Device Recalled for Inter-Lumen Leak

    Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to a reported leak between the cardioplegia and pressure lumens.

    Product
    Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19094·2019-03-28

    Interline Brands Recalls ProPlus Brass Swivel Fittings Due to Fire Hazard

    Interline Brands is recalling ProPlus Brass Flare Swivel Fittings because they can leak, posing a fire hazard. Consumers should contact Interline for a full refund or replacement.

    Product
    ProPlus Brass Flare Swivel Fittings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0953-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International Inc. is recalling specific 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 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0942-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

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

    Product
    AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0949-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International Inc. is recalling 9 units of the Arrow AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks.

    Product
    AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0950-2019·2019-03-06

    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
    AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2019·2019-03-06

    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/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 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-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-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