The Recall Desk

Hazard

Leakage recalls

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

What the numbers show

Total
718
Critical
4
Severe
174
Most recent
2026-10-07

Of the 718 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 174 (24%) are Severe.

Which agencies issued them

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.

626–650 of 718

  • HighFDA (Devices)·Z-1684-2015·2015-06-03

    Codman 3000 Series Refill Set Recalled for Leaking Needles

    Codman & Shurtleff, Inc. is recalling 5,463 units of the CODMAN 3000 Series Refill Set because the needles may leak from the hub connection.

    Product
    CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1660-2015·2015-06-03

    Siemens Immulite 2000 Accessory Kit Recall for Undersized Bottle Openings

    Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Accessory Kits because bottle openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1662-2015·2015-06-03

    Siemens Immulite 2000 Water Feed Kit Recall for Defective Bottle Assemblies

    Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Water Feed Kits because bottle openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1593-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Potential Leakage

    ICU Medical is recalling 5,100 units of MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2015·2015-05-13

    ICU Medical Recalls 98-inch Transfer Sets Due to Connection Separation

    ICU Medical is recalling 50 units of 98-inch Transfer Sets because potential connection separation could lead to leakage.

    Product
    98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1589-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Potential Leakage

    ICU Medical is recalling MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk

    ICU Medical is recalling specific MicroClave T-Connectors because they may separate, causing fluid leakage. The recall affects 250 units distributed in nine US states.

    Product
    119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037 Product Usage: IV Administration sets are intended for the infusion and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk

    ICU Medical is recalling MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk

    ICU Medical is recalling specific MicroClave T-Connectors because they may separate, causing fluid leakage.

    Product
    113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP Tubing, Item No. B33303 Product Usage: IV Administration sets are intended for the infusion and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation

    ICU Medical is recalling 1,500 MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubing, Item No. B33065 Product Usage: IV Administration sets are intended for the infusion and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk

    ICU Medical is recalling 13,800 MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2015·2015-04-01

    BD Q-Syte Luer Access Split Septum Recalled for Leakage

    Becton Dickinson is recalling BD Q-Syte Luer Access Split Septum units due to complaints of blood or medication leakage caused by silicone septum tearing.

    Product
    BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1261-2015·2015-03-18

    Dako Automated Slide Stainers Recalled for Potential Diagnostic Errors

    Dako North America Inc. is recalling four models of automated slide stainers because a defect may cause buffer leakage, leading to false negative diagnostic results.

    Product
    Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2015·2015-02-11

    Baxter Integrated APD Set Recalled for Leakage Complaints

    Baxter Healthcare is recalling 8,640 units of Integrated APD Sets with Cassette 3-Prong due to leakage complaints. The sterile fluid path is used for peritoneal dialysis.

    Product
    Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1053-2015·2015-02-11

    CareFusion Recalls SmartSite Infusion Sets Due to Disconnection and Leakage

    CareFusion is recalling 7,440 SmartSite Low Sorbing Infusion Sets due to disconnection and leakage issues.

    Product
    SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0334-2015·2015-01-14

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Hospira Inc. is recalling 30,840 bags of 0.9% Sodium Chloride Injection, USP, 100mL, due to a potential leak at the administrative port that compromises sterility.

    Product
    0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2015·2014-11-05

    Coloplast Conveen Urine Collection Leg Bag Recalled for Seam Leakage

    Coloplast is recalling Conveen Urine Collection Leg Bags due to potential leakage from the bag seam when filled.

    Product
    Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0089-2015·2014-10-29

    Codman EDS 3 Drainage System Recalled for Potential CSF Leakage

    Codman & Shurtleff is recalling EDS 3 Drainage Systems because tubing may leak or disconnect, risking improper fluid drainage or air introduction.

    Product
    Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0091-2015·2014-10-29

    Codman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage

    Codman & Shurtleff is recalling Lumbar Drainage Catheter Kits because tubing may leak or disconnect, risking improper drainage or air entry.

    Product
    Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0080-2015·2014-10-22

    Baxter 15 L Cycler Drainage Bag Recalled for Potential Drain Tube Leakage

    Baxter Healthcare is recalling 15 L Cycler Drainage Bags because the tube clamp may not fully close, potentially causing leakage.

    Product
    15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2204-2014·2014-08-20

    Gambro Recalls Prismaflex HF 1000 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex HF 1000 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2203-2014·2014-08-20

    Gambro Recalls Prismaflex M150 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M150 dialysis sets because connector breakages can cause liquid or blood to leak.

    Product
    Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2202-2014·2014-08-20

    Gambro Recalls Prismaflex M100 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M100 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2199-2014·2014-08-20

    Gambro Recalls Prisma M100 PRE Pump Infusion Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M100 PRE pump infusion sets because connector breakages can cause liquid or blood to leak.

    Product
    Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states