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.

176–200 of 718

HighFDA (Devices)·Z-1995-2021·2021-07-07
Carefusion Recalls MaxPlus Bi Fuse Extension Sets for Leakage Defect
Carefusion is recalling a batch of MaxPlus Bi Fuse extension sets due to leakage defects. The affected units failed validation testing for leakage and were inadvertently released to the Tennessee market.
Product
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1568-2021·2021-05-19
ICU Medical Recalls Spinning Spiros Male Luers Due to Molding Defect
ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect may cause leakage in the inactivated position.
Product
REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1573-2021·2021-05-19
ICU Medical Recalls Oncology Kits Due to Molding Defect
ICU Medical is recalling specific lots of Oncology Kits with Spinning Spiros due to a molding defect that may cause leakage in the inactivated position.
Product
REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1579-2021·2021-05-19
ICU Medical Recalls Sprios Male Luer Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of Sprios male luer administration sets due to a molding defect that may cause leakage in the inactivated position.
Product
REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1584-2021·2021-05-19
ICU Medical Recalls Sprios IV Adapters Due to Leakage Defect
ICU Medical is recalling specific lots of Sprios IV adapters because a molding defect may cause leakage in the inactivated position.
Product
REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1566-2021·2021-05-19
ICU Medical Recalls Spiros Male Luer Extensions Due to Leakage
ICU Medical is recalling Spiros male luer extensions due to a molding defect that may cause leakage in the inactivated position.
Product
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1583-2021·2021-05-19
ICU Medical Recalls Spiros Transfer Sets Due to Molding Defect
ICU Medical is recalling Spiros transfer sets due to a molding defect that may cause leakage in the inactivated position.
Product
REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1582-2021·2021-05-19
ICU Medical Recalls Sprios Male Luer Administration Sets Due to Leakage
ICU Medical is recalling specific lots of Sprios male luer administration sets due to a molding defect that may cause leakage in the inactivated position.
Product
REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1570-2021·2021-05-19
ICU Medical Recalls Sprios Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of Sprios administration sets because a molding defect may cause leakage in the inactivated position.
Product
REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1585-2021·2021-05-19
ICU Medical Recalls Spiros Closed Male Luer Due to Leakage Defect
ICU Medical is recalling Spiros Closed Male Luer devices due to a molding defect that may cause leakage in the inactivated position.
Product
REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1571-2021·2021-05-19
ICU Medical Recalls Sprios Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that may cause leakage in the inactivated position.
Product
REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1576-2021·2021-05-19
ICU Medical Recalls 20mL Syringes Due to Potential Leakage Defect
ICU Medical is recalling specific lots of 20mL syringes with Spinning Spiros due to a molding defect that may cause leakage in the inactivated position.
Product
REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1569-2021·2021-05-19
ICU Medical Recalls Spinning Spiros Closed Male Luer Due to Leakage
ICU Medical is recalling certain lots of Spinning Spiros Closed Male Luer devices due to a molding defect that may cause leakage in the inactivated position.
Product
REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1577-2021·2021-05-19
ICU Medical Recalls Spinning Spiros Syringes Due to Leakage Defect
ICU Medical is recalling specific lots of 60mL Spinning Spiros syringes because a molding defect may cause leakage in the inactivated position.
Product
REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1567-2021·2021-05-19
ICU Medical Recalls Spiros Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of Spiros administration sets because a molding defect may cause leakage in the inactivated position.
Product
REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1581-2021·2021-05-19
ICU Medical Recalls Admin Sets Due to Potential Leakage Defect
ICU Medical is recalling specific lots of REF 011-CH3967 Admin Sets due to a molding defect that may cause leakage in the inactivated position.
Product
REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1588-2021·2021-05-19
ICU Medical Recalls Spiros Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of Spiros administration sets because a molding defect may cause small amounts of leakage in the inactivated position.
Product
REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1580-2021·2021-05-19
ICU Medical Recalls Smallbore Trifuse Extension Sets Due to Leakage Defect
ICU Medical is recalling specific lots of Smallbore Trifuse Extension Sets because a molding defect may cause leakage in the inactivated position.
Product
REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1578-2021·2021-05-19
ICU Medical Recalls Sprios Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that may cause leakage in the inactivated position.
Product
REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1572-2021·2021-05-19
ICU Medical Recalls Oncology Kits Due to Molding Defect
ICU Medical is recalling specific lots of REF CL3538 Oncology Kits because a molding defect may cause small amounts of leakage in the inactivated position.
Product
REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1565-2021·2021-05-19
ICU Medical Recalls Oncology Kits Due to Molding Defect and Leakage
ICU Medical is recalling specific lots of Oncology Kits due to a molding defect that may cause leakage in the inactivated position.
Product
REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1586-2021·2021-05-19
ICU Medical Recalls Spinning Spiros Male Luers Due to Molding Defect
ICU Medical is recalling specific lots of Spinning Spiros male luers because a molding defect may cause small amounts of leakage in the inactivated position.
Product
REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1590-2021·2021-05-19
ICU Medical Recalls Spinning Spiros Male Luers Due to Leakage Defect
ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect may cause leakage in the inactivated position.
Product
REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1587-2021·2021-05-19
ICU Medical Recalls Bag Spike Adapters Due to Molding Defect
ICU Medical is recalling specific lots of Bag Spike Adapters due to a molding defect that may cause leakage in the inactivated position.
Product
REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1575-2021·2021-05-19
ICU Medical Recalls Smallbore Extension Sets Due to Molding Defect
ICU Medical is recalling specific lots of smallbore extension sets because a molding defect may cause leakage in the inactivated position.
Product
REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the…
Category
Medical Device
Distribution
Distributed nationwide