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.

376–400 of 493

HighFDA (Devices)·Z-0432-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV Monitoring Kits and SafeSet Reservoirs due to a potential leak. The affected units were distributed nationwide.
Product
TRANSPAC¿ IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO¿ FLUSH (INFUSION PUMP), Item No. 42588-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure mo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0497-2017·2016-11-23
ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk
ICU Medical is recalling 30 units of Transpac pressure transducers and SafeSet reservoirs due to a potential leak.
Product
TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08 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-0453-2017·2016-11-23
ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 710 units of Transpac IV transducers with SafeSet Reservoirs due to a potential leak.
Product
TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHOUT COVERS, Item No. 42663-01NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by convertin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0454-2017·2016-11-23
ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 1,480 Transpac IV transducers with SafeSet Reservoirs due to a potential leak. The products were distributed nationwide.
Product
TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS AND WITHOUT COVERS, Item No. 42664-01NS 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0463-2017·2016-11-23
ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 100 units of Transpac IV transducer kits due to a potential leak. The affected items were distributed nationwide.
Product
DOUBLE LINE KIT WITH 03ML FLUSH DEVICE FOR UNIVERSITY OF MICHIGAN HOSP., Item No. 46063-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressur
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0436-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Potential
ICU Medical is recalling 40 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
Product
Transpac¿ IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure Tubing, Item No. 42594-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by convert
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0451-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 1,100 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak. The kits were distributed nationwide.
Product
TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT), Item No. 42645-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0483-2017·2016-11-23
ICU Medical Recalls Transpac Transducer Kits Due to Potential Leak
ICU Medical is recalling 150 units of Transpac transducer kits with SafeSet Reservoirs due to a potential for leak.
Product
TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR ALL CHILDRENS HOSP., Item No. 46076-21 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 ele
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0471-2017·2016-11-23
ICU Medical Recalls Transpac Pressure Transducers Due to Potential Leak
ICU Medical is recalling 336 units of Transpac pressure transducers and SafeSet reservoirs due to a potential for leak.
Product
LEFT HEART KIT FOR PORTLAND ADVENTIST HOSP., Item No. 46066-13 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 t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0542-2017·2016-11-23
ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 120 units of TP4 Monitoring Kits with SafeSet Reservoirs due to a potential leak. The devices are distributed nationwide.
Product
TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-53 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-0558-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.
Product
Transpac¿ IV Monitoring Kit w/Safeset" Blood Sampling Port and 03 ml Squeeze Flush Device 10 cc Sheathed Syringe, Item No. 46109-74 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-0531-2017·2016-11-23
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/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4, Item No. 46098-76 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-0437-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 40 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
Product
Transpac¿ IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure Tubing, Item No. 42594-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by convert
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0486-2017·2016-11-23
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
HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP., Item No. 46076-59 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 cu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0427-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 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 Device, Macrodrip, Item No. 42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by convert
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0372-2017·2016-11-16
Schaerer Surgical Table Floor Locking Cylinders Recalled for Leak Risk
Schaerer Medical USA Inc is recalling replacement floor locking cylinders for model 7300 surgical tables because they may leak due to an incorrect O-ring.
Product
Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0371-2017·2016-11-16
Schaerer 7300 Surgical Tables Recalled for Defective Floor Locking Cylinders
Schaerer Medical USA Inc is recalling four 7300 model surgical tables because defective floor locking cylinders may leak due to incorrect O-rings.
Product
The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0337-2017·2016-11-09
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 may cause hub leaks.
Product
Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. 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
SevereFDA (Devices)·Z-0336-2017·2016-11-09
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/MP XF/6FR/90CM, Model number: H965100460. 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-0346-2017·2016-11-09
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 STRAIGHT XF 5F 100CM, Model number: M003101640. 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-0344-2017·2016-11-09
Stryker Recalls Guider Guide Catheters Due to Manufacturing Defect
Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing non-conformance that could lead to hub leaks.
Product
Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. 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-0342-2017·2016-11-09
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/40 DEG XF/7FR/100 cm, Model number: M003101430 . 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-0340-2017·2016-11-09
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/40 DEG XF/6FR/100 cm, Model number: M003101420. 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-0341-2017·2016-11-09
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 may cause hub leaks.
Product
Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . 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-0347-2017·2016-11-09
Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling Guider Softip XF guide catheters because a manufacturing defect may cause hub leaks in the devices.
Product
Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . 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