Hazard

Fluid Leakage recalls

79 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 79
Critical: 0
Severe: 9
Most recent: 2026-10-07

Of the 79 fluid leakage recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (11%) 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 fluid 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.

26–50 of 79

HighFDA (Devices)·Z-0272-2021·2020-10-28
ICU Medical Recalls APPX NanoClave Manifold Sets Due to Seal Defect
ICU Medical is recalling specific lots of APPX 0.75ml NanoClave Manifold sets because a manufacturing defect may prevent a proper seal.
Product
APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619083929(17)241201(30)50(10)4496182. Administration sets and their accessories are single use, pre-sterilized devices that provide access…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0132-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Potential Fluid Leakage
ICU Medical is recalling Sapphire Epidural Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 26,700 units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0144-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with inline filters because they may leak fluid from air vents. The affected units were distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0142-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters due to a potential for fluid leakage out of air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0126-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 170,735 units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0133-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Potential Fluid Leakage
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0141-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters due to a potential for fluid leakage out of air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0129-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0140-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with Inline Filters due to a potential for fluid leakage out of air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0128-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. 1 unit per pouch; 48 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0134-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers 19,350 units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0136-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filters. The affected units were distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Filter in Sight Chamber, CLAVE Port, 0.2 Micron Filter, CLAVE Y-Site, PE Lined Light Resistant Tubing, Distal Microbore Tubing 272 cm / 15 mL.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0131-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0130-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters because fluid may leak out of the air vents. The recall covers 45,900 units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0138-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 6,400 units distributed in the U.S. and internationally.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0139-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling 521 units of Plum Microbore Infusion Sets because air vents on inline filters may leak fluid. The recall covers nationwide and international distribution.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0127-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage
ICU Medical Inc is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0146-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with Inline Filters due to a potential for fluid leakage out of air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case. Not distributed in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0143-2020·2019-10-23
ICU Medical Recalls Sapphire Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents. The product was distributed in the U.S. and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0147-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0135-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers 4,600 units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0137-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filters. The affected units were distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0145-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical Inc is recalling 7,920 units of Plum Microbore Infusion Sets because fluid may leak from the inline filters.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0106-2020·2019-10-16
Centurion Medical Products Recalls Triple Lumen CVC Kits Due to Connector Defect
Centurion Medical Products is recalling Triple Lumen CVC kits because the included BD MaxZeroNeedleess Connector may allow fluid droplets to separate from the sealed surface after disconnection.
Product
TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0096-2020·2019-10-16
Centurion CVC Insertion Bundle Recalled for Fluid Droplet Risk
Centurion Medical Products is recalling CVC Insertion Bundles because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
Product
CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355
Category
Medical Device
Distribution
Distributed nationwide