Hazard

Leakage recalls

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

What the numbers show

Total: 717
Critical: 4
Severe: 166
Most recent: 2026-08-26

Of the 717 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 166 (23%) 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.

201–225 of 717

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
HighFDA (Devices)·Z-1369-2021·2021-04-14
Hologic Recalls Panther Fusion Tube Trays Due to Potential Leakage
Hologic is recalling 1,355 Panther Fusion Tube Trays because they may leak, potentially causing false positive, false negative, or invalid patient results.
Product
Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0777-2021·2021-01-13
Boston Scientific Recalls Hot AXIOS Stent Delivery Systems Due to Fitting Detachment
Boston Scientific is recalling Hot AXIOS Stent delivery systems because a fitting may detach, risking leakage of bodily contents into the peritoneal cavity.
Product
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0707-2021·2020-12-30
ICU Medical Recalls ChemoLock Administration Sets Due to Molding Defect
ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.
Product
31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35; 3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0706-2021·2020-12-30
ICU Medical Recalls Spiros Male Luer Devices Due to Molding Defect
ICU Medical is recalling Spiros closed male luer devices due to a molding defect that may cause leaks. The defect could lead to infusion delays, fluid contamination, or exposure to hazardous medications.
Product
Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Purple Cap, Bag Hanger, REF: 011-CH3185; 46 cm (18") Appx 7.4 ml, Trifuse Add-On Set w/2 Spiros w/Purple Caps, Bag Spike, 3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0699-2021·2020-12-30
ICU Medical Spiros Administration Sets Recalled for Molding Defect
ICU Medical is recalling Spiros administration sets due to a molding defect that may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
Product
42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8" (2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0702-2021·2020-12-30
ICU Medical Recalls Spiros Male Luer Connectors Due to Molding Defect
ICU Medical is recalling Spiros male luer connectors and administration sets due to a molding defect that may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
Product
30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Luer, REF: CH2000S; Spinning Spiros Closed Male Luer, 10 units, REF: CH2000S-10; S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0703-2021·2020-12-30
ICU Medical Recalls ChemoLock Admin Sets Due to Molding Defect
ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.
Product
30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL3011T; 40" (102 cm) Appx 4.9 ml, Admin Set w
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0709-2021·2020-12-30
ICU Medical Recalls Spinning Spiros Closed Male Luer Components
ICU Medical is recalling specific Spinning Spiros components due to a molding defect that may cause leaks, risking fluid path contamination or exposure to hazardous medications.
Product
Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx 1.5 ml, Bag Spike Adapter w/Spiros, Vented Cap, REF: IB-CH3034C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0708-2021·2020-12-30
ICU Medical Recalls Oncology and Administration Sets Due to Molding Defect
ICU Medical is recalling specific oncology and administration sets because a molding defect in male luers may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
Product
76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 cm(17 IN) Appx 2.9 ml,PUR YELLOW TRANS SET,ChemoClave,CK VLV,Spiros,PURPLE CAP, REF: 011-CH3568; Oncology Kit, 5 Gang Stopcock w/5 ChemoClave,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0710-2021·2020-12-30
ICU Medical Recalls Appx 1.7 ml Bag Spike Due to Molding Defect
ICU Medical is recalling 900 units of Appx 1.7 ml Bag Spike w/Integrated Clave due to a molding defect that may cause leaks in male luers.
Product
Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0558-2021·2020-12-16
MANI Infusion Cannula 23G S Recalled for Luer Connector Defects
Mani, Inc. is recalling MANI Infusion Cannula 23G S units because Luer connector dimensions are out of specification, which may cause fluid leakage or unintended disconnection during ophthalmic surgery.
Product
MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0452-2021·2020-11-25
Cardinal Health Recalls Kangaroo Connect 500ml Bag Sets Due to Leakage
Cardinal Health is recalling Kangaroo Connect 500ml Bag Sets because they may leak at the tube and spike connector interface.
Product
Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0453-2021·2020-11-25
Cardinal Health Recalls Kangaroo Connect 1000ml Bag Sets Due to Leak Risk
Cardinal Health 200, LLC is recalling Kangaroo Connect 1000ml Bag Sets because the feeding spike sets may leak at the tube and spike connector interface.
Product
Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2911-2020·2020-09-09
C.A. Greiner HOLDEX Plastic Cannula Recalled for Sample Leakage
C.A. Greiner & Sohne is recalling 390,000 units of HOLDEX Plastic Cannulas (Lot A19073FK) because sample may leak from the sleeve covering the needle.
Product
Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2795-2020·2020-08-19
Bioseal Trachea Extenders Recalled for Stress Cracks and Leakage Risk
Bioseal Corporation is recalling 900 units of Trachea Extenders due to stress cracks that may cause breathing system leakage, potentially preventing prescribed ventilation from reaching patients.
Product
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2664-2020·2020-07-29
Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, risking leakage of chemicals or blood.
Product
SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN162075 (UDI 00801741119675), AN162075G (UDI 00801741119439)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2668-2020·2020-07-29
Becton Dickinson SafeStep Huber Needle Set Recall for Tubing Cracks
Becton Dickinson is recalling SafeStep Huber Needle Sets with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kits due to potential tubing cracks that may cause leakage.
Product
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2666-2020·2020-07-29
Becton Dickinson Recalls SafeStep Huber Needle Set Port Access Kits
Becton Dickinson is recalling SafeStep Huber Needle Set Port Access Kits because tubing may crack or break, potentially causing leakage of hazardous materials or blood.
Product
SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-00
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2671-2020·2020-07-29
Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, potentially causing leakage of chemicals or biohazard materials.
Product
SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI 00801741066184), LH-0031 (UDI 00801741066207), LH-0032 (UDI 00801741066221), LH-0033 (UDI 00801741066245), LH-0034 (UDI 00801741066269), LH-0035 (UDI 00801741066283), LH-0036 (UDI 0080174106630
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2670-2020·2020-07-29
Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks
Becton Dickinson is recalling PowerLoc MAX Power Injectable Infusion Sets because tubing may crack or break near the Luer or Y site, risking leakage of chemicals or blood.
Product
PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2100-2020·2020-06-03
Cardinal Health Recalls Kangaroo Joey Safety Screw Spike Sets
Cardinal Health is recalling Kangaroo Joey Safety Screw Spike sets because they may leak at the tube and spike connector interface.
Product
Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2103-2020·2020-06-03
Cardinal Health Recalls Kangaroo Epump Safety Screw Spike Sets
Cardinal Health is recalling Kangaroo Epump Safety Screw Spike sets because they may leak at the tube and spike connector interface.
Product
Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2105-2020·2020-06-03
Cardinal Health Recalls Kangaroo 924 Safety Screw Spike Sets
Cardinal Health is recalling Kangaroo 924 Safety Screw Spike Sets because they may leak at the tube and spike connector interface.
Product
Kangaroo 924 Safety Screw Spike Set, Product Code 775759
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2104-2020·2020-06-03
Cardinal Health Recalls Kangaroo Epump Safety Screw Spike Sets
Cardinal Health Inc. is recalling Kangaroo Epump Safety Screw Spike Sets because they may leak at the tube and spike connector interface.
Product
Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659
Category
Medical Device
Distribution
0 states