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.

51–75 of 493

HighFDA (Devices)·Z-0202-2026·2025-10-22
Three valve solution sets recalled from one lot because sets may leak
Baxter is recalling 12,720 CLEARLINK System Continu-Flo solution sets with three luer activated valves from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0197-2026·2025-10-22
Forty four inch extension sets recalled because the IV sets may leak
Baxter is recalling 15,552 CLEARLINK System 44-inch straight-type extension sets from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0193-2026·2025-10-22
Retractable collar solution sets recalled across many lots because sets may leak
Baxter is recalling 958,351 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.
Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0196-2026·2025-10-22
Three valve filtered solution sets recalled because IV sets may leak
Baxter is recalling 8,368 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a 0.2 micron filter from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0203-2026·2025-10-22
Paclitaxel infusion sets recalled from one lot because IV sets may leak
Baxter is recalling 27,072 CLEARLINK System Paclitaxel Sets from one lot because the IV sets may leak.
Product
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0190-2026·2025-10-22
Duo-vent solution sets recalled across three lots because sets may leak
Baxter is recalling 136,512 CLEARLINK System DUO-VENT solution sets across three lots because the IV sets may leak.
Product
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0194-2026·2025-10-22
Three valve retractable collar sets recalled across many lots for leak potential
Baxter is recalling 1,167,120 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.
Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0191-2026·2025-10-22
Non-vented IV solution sets recalled from one lot because sets may leak
Baxter is recalling 1,440 CLEARLINK System non-vented solution sets from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0200-2026·2025-10-22
Filtered extension sets recalled across two lots because IV sets may leak
Baxter is recalling 69,936 CLEARLINK System non-DEHP extension sets with a 1.2 micron filter across two lots because the IV sets may leak.
Product
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0198-2026·2025-10-22
Fourteen inch extension sets recalled from one lot because sets may leak
Baxter is recalling 2,304 CLEARLINK System straight-type extension sets with a retractable collar from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1973-2025·2025-06-18
BD TEXIUM Closed Male Luer Drug Transfer Device Recall
BD TEXIUM Closed Male Luer devices may leak at the interface between the closed male luer component and needle-free connector. The leak could cause procedure delays, treatment interruptions, exposure to hazardous drugs, and underdosing of medication.
Product
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1448-2025·2025-04-02
Medline C-section procedure kits recalled for syringe quality defects
Medline is recalling C-section procedure kits because plastic syringes in the kits may leak or break. The defect was identified in connection with an FDA safety alert and poses a potential risk to patient health.
Product
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1435-2025·2025-04-02
Medline procedure kits with plastic syringes recalled for leaks and breakage
Medline procedure kits containing plastic syringes are recalled for leaks, breakage, and other quality defects identified in an FDA Safety Alert. The recall affects 340 units distributed nationwide in the US and Canada.
Product
Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1453-2025·2025-04-02
Medline Procedure Kits with Defective Syringes Recalled for Leak and Breakage Risk
Medline is recalling C SCOPE Disposable Kits due to plastic syringes affected by quality issues including leaks and breakage that may pose a risk to patient health. The recall affects kits distributed nationwide in the US and Canada.
Product
Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0730-2025·2025-01-01
Abbott 20/30 Indeflator devices recalled for potential leak risk
Abbott Vascular is recalling 20/30 Indeflator devices used in cardiovascular procedures due to potential leaks that could cause air embolism.
Product
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-0731-2025·2025-01-01
Abbott Vascular inflation device may leak during cardiovascular procedures
Abbott Vascular is recalling 20/30 Priority Pack Accessory Kit inflation devices due to potential leaks that could cause air embolism during cardiovascular procedures.
Product
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
Category
Medical Device
Distribution
40 states
SevereFDA (Devices)·Z-0661-2025·2024-12-25
Medtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks
Medtronic Neurosurgery recalls Becker External Drainage and Monitoring Systems due to reports of cracks and leaks in stopcocks. The recalled systems are used to drain cerebrospinal fluid and monitor pressure in neurosurgery patients.
Product
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0662-2025·2024-12-25
Exacta External Drainage System Stopcocks May Leak or Crack
Medtronic Neurosurgery is recalling Exacta External Drainage and Monitoring Systems worldwide due to complaints of cracking and leaking stopcocks. These components control cerebrospinal fluid drainage and intracranial pressure monitoring.
Product
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0339-2025·2024-11-20
IV Fluid Container Bags Recalled for Potential Leaks During Filling
The Metrix Company is recalling SECURE 250 mL IV fluid containers due to leaks found during filling. Affected units were distributed nationwide and to Canada.
Product
SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0334-2025·2024-11-20
IV Bag Containers Recalled for Leaking During Filling Process
The Metrix Company is recalling CORMIX 500 mL IV bag containers that may leak during the filling process. These plastic pouches are intended for intravenous fluid administration.
Product
CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0331-2025·2024-11-20
VYGON 250 mL IV Fluid Containers Recalled for Leaks During Filling
The Metrix Company is recalling VYGON 250 mL IV fluid containers that have been found to leak during filling. Leaking containers cannot properly contain intravenous fluid.
Product
VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0337-2025·2024-11-20
IV Fluid Pouches Found to Leak During Filling
The Metrix Company is recalling SECURE 50 mL EVA containers used for intravenous fluid administration because a limited number of pouches have been found to leak during filling. Affected products were distributed nationwide and to Canada.
Product
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0194-2025·2024-10-30
Smiths Medical TranStar Pressure Transducers Recalled Due to Manufacturing Defect
Smiths Medical is recalling 1,000 units of medex TranStar DPT pressure transducers that may monitor inaccurately or interrupt monitoring due to a manufacturing defect. Users may be unable to zero the device.
Product
medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3036-2024·2024-09-18
Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes
Medline is recalling medical convenience kits containing plastic syringes that may leak or break. These quality defects, linked to an FDA safety alert, pose a potential risk to patient health.
Product
Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408VH; 3) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492A ; 4) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492AH; 5)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2993-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage
Medline is recalling multiple medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects identified in an FDA Safety Alert. The affected kits are used in various medical procedures.
Product
Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT
Category
Medical Device
Distribution
0 states