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.

301–325 of 493

  • HighFDA (Devices)·Z-0534-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 140 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit w/03 ml Squeeze Flush, Pressure Tubing, Guidewire, 10 cc Syringes and 3 Way Stopcock, Item No. 46098-87NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0548-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential

    ICU Medical is recalling 220 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into el
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0560-2017·2016-11-23

    ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 100 units of Transpac IV Trifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0450-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 60 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML INTRAFLO¿ FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42651-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducer Kits Due to Leak Risk

    ICU Medical is recalling 90 units of Transpac pressure transducer kits due to a potential leak in the SafeSet Reservoir.

    Product
    DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0431-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Potential

    ICU Medical is recalling 4,360 Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling kits.

    Product
    TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT), Item No. 42587-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0469-2017·2016-11-23

    ICU Medical Recalls Transpac Transducer Kits Due to Leak Risk

    ICU Medical is recalling 175 Transpac transducer kits with SafeSet Reservoirs due to a potential leak hazard.

    Product
    ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-64 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0538-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV transducer kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ 4 kit w/72" Macrodrip¿ Admin Set, Item No. 46099-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0519-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 120 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV monitoring kits because the SafeSet Reservoir and blood sampling components may leak.

    Product
    TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MICRODRIP¿ (POLE MOUNT), Item No. 42607-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 140 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-46106-45 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting chan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV transducer kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-65 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting change
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 1,240 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0570-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac¿ IV, 2 Admin Sets and 8 cc Control Syringe, Item No. 46300-01 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0510-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 210 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2017·2016-11-23

    ICU Medical Recalls Transpac Transducer Kits Due to Leak Risk

    ICU Medical is recalling 60 units of Transpac IV transducer kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical curre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 200 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-49 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into el
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0552-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 20 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling kits.

    Product
    Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo¿ Flush, Pall Air Filter, Macrodrip (Pole Mount), Item No. 46104-63 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 30 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item No. 46098-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in press
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 3,480 Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQUEEZE FLUSH, MACRODRIP, 60", DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42584-09 The Transpac Disposable Straight Pressure Transducer (DSPT) is an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0556-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 210 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Bifurcated Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Red and Blue Stripe PT Tubing, Item No. 46107-68 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 40 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit w/3 Port "ON" Manifold, 03 ml Flush Device, Waste Bag, HPT, Syringe, TP4 and 30 ml Contrast Reservoir, Item No. 46095-16 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2017·2016-11-23

    ICU Medical Recalls Cardiac Catheterization Kits Due to Leak Risk

    ICU Medical is recalling 70 cardiac catheterization kits containing Transpac IV transducers due to a potential leak in the SafeSet Reservoir system.

    Product
    Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item No. 46083-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a cat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0541-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 40 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Transpac¿ IV and 48" HP Tubing, Item No. 46100-87 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monito
    Category
    Medical Device
    Distribution
    Distributed nationwide