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.

651–675 of 717

  • HighFDA (Devices)·Z-2195-2014·2014-08-20

    Gambro Recalls Prisma M 60 PRE Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M 60 PRE sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2193-2014·2014-08-20

    Gambro Recalls Prismaflex TPE 2000 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex TPE 2000 sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2201-2014·2014-08-20

    Gambro Recalls Prismaflex M60 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M60 sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2196-2014·2014-08-20

    Gambro Recalls Prisma M60 Postdilution Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M60 POSTDILUTION sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2205-2014·2014-08-20

    Gambro Recalls Prismaflex HF 1400 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex HF 1400 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2200-2014·2014-08-20

    Gambro Recalls Prisma HF1000 Presets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma HF1000 presets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2194-2014·2014-08-20

    Gambro Recalls Prisma TPE 2000 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma TPE 2000 sets because connector breakages can cause liquid or blood leakage.

    Product
    Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2197-2014·2014-08-20

    Gambro Recalls Prisma M 100 PRE Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M 100 PRE sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2198-2014·2014-08-20

    Gambro Recalls Prisma M100 Sets Due to Connector Breakage

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

    Product
    Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2207-2014·2014-08-20

    Gambro Recalls X-MARS Sets Due to Connector Breakage and Leakage

    Gambro Renal Products is recalling X-MARS Sets because connector breakages can cause leakage of liquid or blood.

    Product
    X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·14249·2014-08-05

    Scubapro Aladin2 Dive Computers Recalled for Decompression Sickness Risk

    Johnson Outdoors Diving is recalling Scubapro Aladin2 dive computers because they may leak and stop working, posing a risk of injury from decompression sickness.

    Product
    Scubapro Aladin2 dive computers, commonly referred to as Aladin Square dive computers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1959-2014·2014-07-09

    Atrium Express Dry Seal Chest Drain Recall Due to Leaking Risk

    Atrium Medical Corporation is recalling 1,170 units of the Express Dry Seal Chest Drain ATS Blood Recovery because the tubing may leak or disconnect.

    Product
    Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1609-2014·2014-05-21

    FDA Recalls Defective Ultrasound Needles That May Leak at Hub

    RM Temena GmbH is recalling ultrasound needles that may leak at the hub. The recall involves 7,370 needles distributed in the US.

    Product
    Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1608-2014·2014-05-21

    FDA Recalls Defective Ultrasound Needles That May Leak at Hub

    RM Temena GmbH is recalling 7,370 ultrasound needles that may leak at the needle hub. The defective needles were distributed in Maryland and Illinois.

    Product
    Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1459-2014·2014-04-23

    CareFusion SmartSite Extension Set Recalled for Tubing Disconnections and Leaks

    CareFusion 303, Inc. is recalling 7,700 SmartSite Extension Sets due to disconnections and leakages at the tubing and Y-port connection.

    Product
    SmartSite Extension Set, Model No. 20029E, intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2014·2014-04-16

    Smiths Medical HOTLINE Fluid Warming Set Recall for Injection Port Leaks

    Smiths Medical is recalling HOTLINE Fluid Warming Sets because the injection port septum may leak or become dislodged.

    Product
    Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1315-2014·2014-04-09

    Roche Omni Micro-electrode Recalled for Potential Leakage and Erroneous Results

    Roche Diagnostics is recalling Omni Micro-electrodes for cobas b221 analyzers because they may leak if used beyond their 52-week lifetime, potentially causing erroneous pH and sodium results.

    Product
    Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2014·2014-03-05

    Fresenius Recalls Optiflux F18Nre Dialyzers Due to Port Leak Risk

    Fresenius Medical Care is recalling 34,752 Optiflux F18Nre Flux Dialyzers because the dialysate port may leak during priming.

    Product
    Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2014·2014-02-26

    B. Braun Recalls SAFSITE Injection Sites and IV Sets Due to Leakage

    B. Braun Medical is recalling specific lots of SAFSITE Injection Sites and IV Sets because complaints reported leakage. The devices are used for needle-free access on IV and extension sets.

    Product
    SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1540-2014·2014-02-26

    Abbott Nutrition Recalls Similac Human Milk Fortifier Powder Packets

    Abbott Nutrition is recalling Similac Human Milk Fortifier Powder packets in Canada due to incomplete seals that may allow air entry, causing oxidation or powder leakage.

    Product
    Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT ADD WATER NET WT 0.031 OZ (0.90g)***CONTAINS MILK AND SOY INGREDIENTS***USE BY***ABBOTT LABORATORIES"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0925-2014·2014-02-12

    CareFusion Recalls SmartSite Needleless Connectors Due to Connection Issues

    CareFusion is recalling SmartSite Needleless Connectors because they may unintentionally disconnect, be difficult to disconnect, or fail to disconnect from a female luer.

    Product
    SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0931-2014·2014-02-12

    CareFusion Recalls Trifurcated Extension Sets Due to Potential Component Leak

    CareFusion 303, Inc. is recalling Trifurcated Extension Sets (models ME 1224 and MP 9230) because a defect in the trifurcated component could result in a leak.

    Product
    Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1035-2014·2014-02-05

    Hospira Recalls Aminosyn 3.5% Bags Due to Sterility Concerns

    Hospira Inc. is recalling 15,258 bags of Aminosyn 3.5% M Sulfite-Free due to a lack of assurance of sterility and potential leakage from the administrative port.

    Product
    Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1036-2014·2014-02-05

    Hospira Recalls Heparin Sodium Bags Due to Sterility Concerns

    Hospira is recalling 27,780 bags of Heparin Sodium 2000 USP Units per 1000 mL due to a lack of assurance of sterility and potential leakage from the administrative port.

    Product
    HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0737-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain ATS Recall for Tubing Leaks

    Atrium Medical Corporation is recalling 6,684 Ocean Water Seal Chest Drain ATS units because the chest drain tubing may leak or disconnect.

    Product
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide