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.

101–125 of 717

  • HighFDA (Devices)·Z-2775-2024·2024-09-04

    Medical procedure packs containing defective syringes recalled by Medline

    Medline is recalling Centurion procedure packs with plastic syringes that have leaks, breakage, and other quality issues. These defects may pose a risk to patient health.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH1512A; 3) CIRCUMCISION TRAY, Pack Name CIT6720; 4) CIRCUMCISION TRAY, Pack Name CIT6715; 5) CIRCUMCISION TRAY, Pack Name CIT7
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2574-2024·2024-08-21

    Merit Medical cardiac kits contain plastic syringes with quality defects

    Merit Medical convenience kits used in cardiac procedures contain plastic syringes with potential leaks and breakage. The defects were identified following an FDA Safety Alert issued March 19, 2024.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2572-2024·2024-08-21

    Merit Medical Convenience Kits with Defective Syringes Recalled

    Merit Medical convenience kits containing defective syringes are being recalled for leaks and breakage that may pose a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude Prestige (Introducer Catheter), REF: PLP-2505/A PLP-2514/A PLP-2516/A The introduction of various types of pacing/defibrillator leads and catheters i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2577-2024·2024-08-21

    Merit Medical Catheter Kits Recalled for Syringe Leaks and Breakage Issues

    Merit Medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues that may harm patients. The recall affects approximately 4,027 kits distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-CSG-B1-09/A WOR-CSG-B2-09/A WOR-CSG-BL1-09/A WOR-CSG-E-90/A For the int
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2024·2024-08-21

    Merit Medical Convenience Kits With Recalled Syringes Pose Quality Defect Risks

    Merit Medical convenience kits containing recalled syringes are subject to a nationwide recall due to quality defects including leaks and breakage that may pose risks to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2567-2024·2024-08-21

    Convenience kits by Merit Medical recalled for syringe defects

    Merit Medical convenience kits containing defective syringes have been recalled nationwide. Identified quality issues including leaks and breakage may pose risks during cardiac and vascular procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2559-2024·2024-08-21

    Merit Medical catheter extractor kits recalled for syringe quality defects

    Merit Medical is recalling 3,631 catheter extractor convenience kits due to defective syringes with leaks and breakage. The identified quality issues may compromise patient safety during catheter removal.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Outake, REF CET200 and CET300, The Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2442-2024·2024-08-14

    Medline Medical Procedure Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling over 1.6 million medical procedure kits nationwide and internationally due to plastic syringe defects. The affected kits contain syringes with leaks, breakage, and quality issues that may pose risks to patient health.

    Product
    Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2443-2024·2024-08-14

    Medline Procedure Kits Recalled Due to Defective Plastic Syringes

    Medline procedure kits containing defective plastic syringes are being recalled nationwide. The syringes may leak, break, or have other quality issues that could pose a risk to patient health.

    Product
    Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2024·2024-04-17

    EndoVive 20 Fr Feeding Tube May Obstruct During Placement

    Boston Scientific is recalling EndoVive 20 Fr feeding tubes due to potential blockage during placement that may prevent guidewire advancement. This could lead to procedure complications including bleeding, gastric leakage, or aspiration.

    Product
    EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509191
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0431-2024·2024-04-10

    Lactated Ringers IV Solution Recall: Potential Sterility Failure Risk from Bag Leakage

    B. Braun Medical Inc. is recalling approximately 7,800 bags of Lactated Ringers IV solution (Lot J3N023, exp. March 31, 2026) distributed nationwide due to potential leakage that could compromise sterility.

    Product
    LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0365-2024·2024-03-13

    Clindamycin Phosphate Topical Solution recalled due to defective container leakage

    Contract Pharmaceuticals Limited Canada is recalling Clindamycin Phosphate Topical Solution 1% due to defective containers with slow leakage. Lot 119874 (expires 06/30/2025) distributed nationwide in the U.S. and Puerto Rico is affected.

    Product
    Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0942-2024·2024-02-07

    EZDilate Wire Guided Balloon Recalled for Device Malfunction and Patient Injury Risk

    Olympus recalled 3,767 EZDilate Wire Guided Balloons due to reported inflation, deflation, and retrieval problems causing bursting, leaking, and foreign body lodgement in patients. The devices dilate strictures in the alimentary tract.

    Product
    EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1555
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0936-2024·2024-02-07

    EZDilate Endoscopic Balloon Devices Recalled for Malfunction and Foreign Body Risk

    Olympus is recalling EZDilate Fixed Wire Balloon devices used for esophageal stricture treatment due to reports of inflation/deflation failures, bursting, leaking, and foreign body retention in patients.

    Product
    EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2024·2023-12-20

    Medical Device Recall: Para-Pak Zn-PVA Stool Collection Vials for Leakage Risk

    Meridian Bioscience is recalling Para-Pak Zn-PVA stool specimen collection vials due to a manufacturing defect that may cause leakage and risk exposure to biological hazards.

    Product
    Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0521-2024·2023-12-20

    Cardinal Health Stool Transportation System Recalled for Vial Leakage

    Meridian Bioscience is recalling the Cardinal Health Clean Stool Transportation System due to a manufacturing defect that may cause Para-Pak vials to leak. Affected product: 38 cases with Lot Number 510020Q, distributed nationwide and to Italy.

    Product
    Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2024·2023-12-13

    Medical Catheter Sets Recalled Due to Bonding Material Defect

    CooperSurgical H/S Catheter Sets may have defective bonding material causing component detachment or leakage. The sets are used in hysterosalpingography procedures to detect uterine abnormalities.

    Product
    CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2024·2023-12-13

    Medical Catheter Set Recalled for Faulty Bonding Material

    CooperSurgical is recalling H/S ELLIPTOSPHERE CATH 5 FR Sets (169 units) due to incorrect bonding material that may cause component detachment or leakage, potentially delaying diagnostic procedures.

    Product
    Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes Model: 61-40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0502-2024·2023-12-13

    Cooper Surgical catheter recall due to component detachment risk

    The Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr catheter may detach or leak due to defective bonding material used in assembly. The 73 affected units were distributed nationwide and internationally.

    Product
    Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model: 61-3005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2024·2023-11-15

    SA3000 intravenous adapters recalled for manufacturing defect causing leakage

    B. Braun is recalling SA3000 intravenous adapters due to a manufacturing defect that may cause leakage. This could delay therapy, increase bloodstream infection risk, and expose patients and workers to hazardous medication.

    Product
    SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0130-2024·2023-11-15

    B. Braun AMO Administration Set Recalled for Manufacturing Defect Causing Leakage

    B. Braun Medical is recalling AMO ophthalmologic administration sets due to a manufacturing defect causing potential leakage. This may delay therapy and expose patients and healthcare workers to hazardous medication.

    Product
    AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2024·2023-11-15

    IV Injection Set Recall: Risk of Leakage and Bloodstream Infection

    B. Braun Medical is recalling 12,800 units of TERUMO IV injection sets (Lot 0061753485) due to a manufacturing defect that may cause leakage, delaying therapy and increasing risk of bloodstream infection.

    Product
    TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2024·2023-11-15

    Burette Assembly Recalled for Manufacturing Defect Causing Potential Leakage

    B. Braun recalls 30 ML 2PORT burette assemblies (lot 0061766049) for potential leakage due to manufacturing defect. Leakage risks delayed therapy, bloodstream infection, and medication exposure to patients and healthcare workers.

    Product
    30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2024·2023-11-15

    Medical administration set for radiation therapy recalled due to leakage risk

    B. Braun Medical recalls THERASPHERE ADMIN SET due to manufacturing defects causing potential leakage. Leakage may delay therapy, increase bloodstream infection risk, and expose patients and healthcare workers to hazardous medication.

    Product
    THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0136-2024·2023-11-15

    IV Fitting Components Recalled Due to Manufacturing Defect and Leakage Risk

    B. Braun Medical is recalling 175,000 units of bulk largebore male LL fittings due to a manufacturing defect that may cause leakage, potentially increasing bloodstream infection risk.

    Product
    BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.
    Category
    Medical Device
    Distribution
    Distributed nationwide