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.

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 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.

401–425 of 493

HighFDA (Devices)·Z-0339-2017·2016-11-09
Stryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing defect that could cause hub leaks.
Product
Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0343-2017·2016-11-09
Stryker Neurovascular Recalls Guider Softip XF Guide Catheters
Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.
Product
Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0345-2017·2016-11-09
Stryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing defect that could cause hub leaks.
Product
Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0334-2017·2016-11-09
Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.
Product
Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2817-2016·2016-09-21
ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 110 units of Double Kit with SafeSet and 03mL Flush Device due to a potential for leak.
Product
Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2809-2016·2016-09-21
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.
Product
Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84" Tubing, Disposable Transducer, 3 mL Squeeze Flush, Macrodrip (Pole Mount), Item No. 42646-06 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2807-2016·2016-09-21
ICU Medical Recalls Transpac IV Bifurcated Kits Due to Leak Risk
ICU Medical is recalling 10 units of Transpac IV Bifurcated Kits with SafeSet Reservoirs due to a potential for leaks.
Product
Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2814-2016·2016-09-21
ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential
ICU Medical is recalling 20 units of Single Monitoring Kits with 30mL Flush Devices due to a potential for leak in the SafeSet Reservoir and blood sampling components.
Product
Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product Usage: 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2824-2016·2016-09-21
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 100 units of Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak hazard.
Product
Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2827-2016·2016-09-21
ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk
ICU Medical is recalling 150 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 with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2806-2016·2016-09-21
ICU Medical Recalls Transpac IV Trifurcated Kits Due to Leak Risk
ICU Medical is recalling 250 units of Transpac IV Trifurcated Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
Product
Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transducers, Macrodrip, Item No. 42500-04 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure tra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2832-2016·2016-09-21
Circulatory Technology Recalls Bigger-Better-Bladder 2 Devices Due to Seal Leak
Circulatory Technology Inc is recalling 20 units of the Bigger-Better-Bladder, TM 2 device because the seal between the balloon and housing may leak.
Product
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal c
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-2818-2016·2016-09-21
ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits
ICU Medical is recalling 70 units of SafeSet Reservoir and blood sampling kits due to a potential leak.
Product
Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: 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 electric
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2821-2016·2016-09-21
ICU Medical Recalls Pediatric Pressure Transducer Kits Due to Leak Risk
ICU Medical is recalling 20 Pediatric Kits with 30mL Flush Devices due to a potential leak in the SafeSet Reservoir and blood sampling components.
Product
Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: 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 electric
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2825-2016·2016-09-21
ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 140 units of TP4 Kits with SafeSet Reservoirs due to a potential for leaks. The affected medical devices were distributed nationwide.
Product
TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by conve
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2819-2016·2016-09-21
ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 125 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: 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-2812-2016·2016-09-21
ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk
ICU Medical is recalling 760 Transpac IV Trifurcated Monitoring Kits because of a potential for leaks in the SafeSet Reservoir and blood sampling components.
Product
Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macrodrip (Pole Mount), Item No. 42650-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extrava
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2820-2016·2016-09-21
ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
ICU Medical is recalling 20 units of Bifurcated SafeSet Kits with 03mL Flush Devices due to a potential for leaks.
Product
Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2813-2016·2016-09-21
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 90 units of Transpac IV Trifurcated Monitoring Kits due to a potential for leaks in the SafeSet Reservoir and blood sampling components.
Product
Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a cathe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2822-2016·2016-09-21
ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 10 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: 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-2826-2016·2016-09-21
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.
Product
Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valves, Mounts and Bracket, Item Nos. 46107-35, 46110-07 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2828-2016·2016-09-21
ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential
ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usage: 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-2811-2016·2016-09-21
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 with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient Mount), Item No. 42648-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pre
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2823-2016·2016-09-21
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
Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in p
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2808-2016·2016-09-21
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential for leaks in the SafeSet Reservoir and blood sampling components.
Product
Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole Mount), Item No. 42619-08 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
Category
Medical Device
Distribution
Distributed nationwide