The Recall Desk

Hazard

Leaking recalls

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

What the numbers show

Total
181
Critical
1
Severe
38
Most recent
2026-08-12

Of the 181 leaking recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 38 (21%) 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 leaking 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.

1–25 of 181

  • HighFDA (Devices)·Z-2865-2026·2026-08-12

    Stryker Single Spike Tube Set Recalled for Leaking During Use

    Stryker is recalling 11,857 Single Spike Tube Sets due to reports of leaking from the handpiece during use.

    Product
    STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2863-2026·2026-08-12

    Stryker Ahto Tube Set Recalled for Handpiece Leaking During Use

    Stryker is recalling 41,052 Ahto Tube Sets worldwide due to reports of handpiece leaking during use.

    Product
    STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2866-2026·2026-08-12

    Stryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use

    Stryker is recalling Strykeflow Suction/Irrigator PS devices due to reports of leaking from the handpiece during use.

    Product
    STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2025·2025-06-18

    BD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk

    BD TEXIUM closed male luer drug transfer devices may leak at the interface between the closed male luer component and the needle-free connector, potentially causing procedure delays, treatment interruptions, hazardous drug exposure, and medication underdosing.

    Product
    BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Leaking at Seal Interface

    Medline is recalling sterile water and 0.9% normal saline bottles due to leaking at the peel-foil and bottle opening interface. The defect affects 159 units distributed nationwide and internationally.

    Product
    Medline procedure kits, labeled as: HAND, REF DYNJ902002J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1705-2025·2025-05-07

    Medline Sterile Water USP bottles recalled for leaking at peel-foil interface

    Medline Sterile Water, USP 100mL bottles are being recalled because they leak at the interface between the peel-foil and bottle opening, posing a contamination risk.

    Product
    Medline Sterile Water, USP, 100mL, REF RDI30295
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1713-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Recalled for Leaking

    Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.

    Product
    Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0335-2025·2024-11-20

    IV Fluid Container Bags Recalled for Leaking Defect

    The Metrix Company is recalling SECURE 100 mL empty EVA containers for IV use due to leaking discovered during filling. Approximately 2,229 cases were distributed to healthcare facilities in the US and Canada.

    Product
    SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0341-2025·2024-11-20

    Metrix SECURE 1000 mL IV Container Recall Due to Leaking

    The Metrix Company is recalling SECURE 1000 mL empty IV containers because a limited number were found to leak during filling.

    Product
    SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2025·2024-11-20

    Imed EVA IV bags recalled for leaking during filling

    The Metrix Company is recalling Imed EVA 500 mL IV bags because a limited number have been found to leak during filling. Affected lots were distributed nationwide in the U.S. and Canada.

    Product
    Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3001-2024·2024-09-18

    Medline Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage

    Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and other quality defects that may pose a risk to patient health. Kits are distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack Number CDS983181D ; 3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ; 4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ; 5) MEDIASTIN
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3006-2024·2024-09-18

    Medline Convenience Kits with Plastic Syringes Recalled for Defects

    Medline medical convenience kits containing plastic syringes are being recalled due to identified quality issues including leaks and breakage that may pose a risk to patient health. Products were distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ; 2) LAVH CDS, Pack Number CDS760049AC; 3) LAPAROSCOPY CDS , Pack Number CDS760051AB; 4) LAPAROSCOPY CDS , Pack Number CDS760051AC; 5) LAPAROSCOPY CDS , Pack Number CDS760051AD; 6) ABDOM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3003-2024·2024-09-18

    Medline Breast Biopsy Kits Recalled for Syringe Quality Issues

    Medline is recalling multiple breast biopsy convenience kits with plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, and quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2566-2024·2024-08-21

    Merit Medical Pressure Monitoring Kits with Defective Syringes Recalled

    Merit Medical is recalling 69 convenience kits containing defective syringes that may leak or break, potentially risking patient safety during medical procedures. The kits were distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring Kit), REF: K11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0933-2024·2024-02-07

    EZDilate esophageal balloons recalled for inflation failure and device leaking

    Olympus is recalling EZDilate Fixed Wire Balloons for inflation and deflation failures. The devices may burst, leak, or leave foreign material in patients.

    Product
    EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0941-2024·2024-02-07

    Endoscopic Dilation Balloons Recalled for Bursting and Leaking Failures

    Olympus recalled 3,354 EZDilate wire-guided dilation balloons due to failures in inflation, deflation, and retrieval, with incidents of bursting, leaking, and foreign bodies left in patients.

    Product
    EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0935-2024·2024-02-07

    Olympus EZDilate Fixed Wire Balloon Device Recalled for Inflation and Deflation Failures

    Olympus recalls 1,008 EZDilate Fixed Wire Balloon devices nationwide due to malfunction during use. Reported failures include inflation and deflation problems, bursting, leaking, and foreign body events in patients.

    Product
    EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2024·2024-02-07

    EZDilate Fixed Wire Balloon Medical Device Recalled Due to Device Failures

    Olympus is recalling 8,294 EZDilate Fixed Wire Balloon devices due to reports of device failures including bursting, leaking, and foreign body retention in patients undergoing esophageal dilation.

    Product
    EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2024·2024-02-07

    Olympus EZDilate Balloon Dilators Recalled for Device Malfunction and Retained Foreign Bodies

    Olympus recalled EZDilate Wire Guided Balloon endoscopic dilators due to reports of bursting, leaking, and retained foreign bodies during patient procedures. The Class II recall affects 4,182 units used to treat esophageal strictures.

    Product
    EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2023·2023-07-26

    Infant Heel Warmer Recalled Due to Burst and Leaking

    Cardinal Health is recalling 44,500 NovaPlus Infant Heel Warmers from lot V2S056 due to reports of bursting and leaking. Units were distributed nationwide.

    Product
    NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0684-2023·2023-04-05

    Canned Geisha Medium Shrimp Recalled for Leaking Containers

    Kawasho Foods USA is recalling Geisha Medium Shrimp 4 oz cans due to leaking and bulging containers. The defect may compromise food safety.

    Product
    Geisha Medium Shrimp; WT 4OZ(113g)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1685-2022·2022-09-07

    Sucrose solution vials recalled nationwide for contamination and leaking

    Clinical Innovations is recalling Sweetums 24% sucrose solution vials due to reports of leaking containers and contamination with black liquid and particulates. The product is used in hospital settings including neonatal intensive care units.

    Product
    Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setting
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1684-2022·2022-09-07

    Clinical Innovations Sweetums Sucrose Solution Vials Recalled for Contamination

    Clinical Innovations is recalling Sweetums 24% sucrose solution vials due to complaints of leaking, black liquid, and black particulates in product vials. The recall affects neonatal products distributed nationwide and internationally.

    Product
    Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0795-2022·2022-03-23

    Lumbar Puncture Tray Adult recalled due to manometer failure and leaking

    Bard Peripheral Vascular Inc is recalling 8,630 lumbar puncture trays due to manometer failure causing leaking and mating issues. Devices were distributed nationwide in the U.S. plus Puerto Rico, Costa Rica, and Hong Kong.

    Product
    LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
    Category
    Medical Device
    Distribution
    Distributed nationwide