Hazard

Leakage recalls

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

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.

26–50 of 152

HighFDA (Devices)·Z-1972-2025·2025-06-18
BD Texium Drug Transfer Devices May Leak at Connector Interface
BD Texium closed-system drug transfer devices may leak at the connector interface, potentially causing treatment delays, drug exposure, and medication underdosing. Over 812,000 units are affected worldwide.
Product
BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2025·2025-04-02
Medline Procedure Kits With Defective Plastic Syringes Recalled
Medline is recalling surgical procedure kits with plastic syringes affected by a March 2024 FDA Safety Alert due to leaks, breakage, and quality issues that may pose risks to patients.
Product
Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pac
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1444-2025·2025-04-02
Medline surgical procedure kits recalled for syringe leaks and breakage
Medline procedure kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits were distributed nationwide in the US and Canada.
Product
Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1393-2025·2025-03-26
Medline C-Section Procedure Kits Recalled for Defective Syringes
Medline is recalling 456 C-section procedure kits containing plastic syringes affected by an FDA safety alert. The syringes may leak or break, posing a risk to patient health during surgical procedures.
Product
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1397-2025·2025-03-26
IV Catheter Valve Housing May Detach and Cause Leakage
B. Braun Medical is recalling Introcan Safety 3 IV catheters because the valve housing may detach, causing fluid leakage. Approximately 28,200 units are affected.
Product
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-1394-2025·2025-03-26
Medline Medical Convenience Kits Recalled for Defective Plastic Syringes
Medline is recalling 880 medical convenience kits containing plastic syringes with potential leaks and breakage. The syringes were identified as defective and may pose health risks to patients.
Product
Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0257-2025·2025-03-19
Sodium Chloride Injection Recalled for Potential Sterility Compromise
Nephron Sterile Compounding Center is recalling Sodium Chloride Injection 9% due to potential leakage at the IV bottle port, which could compromise sterility. Affected lots were distributed nationwide.
Product
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0252-2025·2025-03-12
Ferrous Sulfate Oral Syringes Recalled Due to Leakage Defect
Safecor Health is recalling 1535 Ferrous Sulfate 7.5 mg oral syringes distributed nationwide due to leakage observed during repackaging. The defective delivery system could result in improper dosing of the iron supplement.
Product
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0254-2025·2025-03-12
Morphine Sulfate Oral Syringes Recalled for Defective Delivery System Leakage
Safecor Health is recalling Morphine Sulfate 5 mg oral syringes nationwide due to leakage in the delivery system following repackaging. No illnesses have been reported.
Product
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0250-2025·2025-03-12
Vitamin D Supplement Oral Syringes Recalled for Defective Delivery System
Safecor Health is recalling 3069 units of Ergocalciferol (Vitamin D Supplement) oral syringes nationwide due to leakage in the repackaged unit-dose delivery system. No illnesses have been reported.
Product
Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0251-2025·2025-03-12
Simethicone Oral Syringe Recalled for Defective Delivery System
Safecor Health is recalling Simethicone 20 mg oral syringes due to leakage caused by a defective delivery system. Approximately 10,992 syringes were distributed nationwide.
Product
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0340-2025·2024-11-20
IV Fluid Container Leak During Filling — SECURE 500 mL EVA Container Recall
The Metrix Company is recalling SECURE 500 mL EVA containers (REF 66050) used for intravenous administration because a limited number have been found to leak during filling. Affected lots were distributed nationwide and to Canada.
Product
SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; 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-0338-2025·2024-11-20
IV Fluid Bags Recalled Due to Leakage During Filling
The Metrix Company is recalling SECURE 50 mL empty IV containers due to leakage found during filling. A limited number of affected bags have been distributed nationwide.
Product
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; 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-0332-2025·2024-11-20
IV Fluid Containers Recalled for Leakage Risk During Filling
The Metrix Company is recalling CORMIX 150 mL empty IV fluid containers due to leakage found during filling, which could compromise the integrity of intravenous fluids.
Product
CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; 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-0336-2025·2024-11-20
IV Fluid Bags Found to Leak During Filling; Manufacturer Recalls Affected Units
The Metrix Company is recalling 2549 cases of SECURE 100 mL empty IV fluid bags because a limited number were found to leak during filling, which could result in contamination during fluid administration.
Product
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; 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-0342-2025·2024-11-20
IV Fluid Bags Recalled Due to Leaking During Filling
The FDA is recalling Imed EVA BAG IV bags after a limited number were found to leak during filling. The affected bags were distributed nationwide and in Canada.
Product
Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; 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-0345-2025·2024-11-20
Imed EVA IV bags recalled for leaking during filling
The Metrix Company is recalling Imed EVA IV bags due to leakage discovered during the filling process. A limited number of bags were found to leak, potentially affecting the safety of intravenous therapy.
Product
Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; 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-0343-2025·2024-11-20
Imed EVA IV Fluid Bags Recalled Due to Leakage During Filling
The Metrix Company is recalling Imed EVA IV fluid bags that may leak during filling. A limited number of units have been found defective across multiple U.S. states and Canada.
Product
Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; 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-0263-2025·2024-11-06
Westmed Flex Extenders recalled for connector failure risk
Westmed is recalling Flex Extenders because connectors may fail to hold properly, potentially causing the breathing circuit to leak or disconnect and creating life-threatening conditions. Over 50,000 units are affected across multiple U.S. states.
Product
1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight conne
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-2999-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Defective Plastic Syringes
Medline is recalling medical convenience kits containing plastic syringes affected by quality issues including leaks and breakage. The defects may pose risks during dental and surgical procedures.
Product
Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) ORAL PACK-LF, Pack Number DYNJ0426048L ; 4) ORAL SURGERY PACK-LF, Pack Number DYNJ17477F ; 5) ORAL SURGERY PACK-LF, Pack Number
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3052-2024·2024-09-18
Medline surgical convenience kits recalled due to defective plastic syringes
Medline Industries is recalling multiple surgical convenience kits containing defective plastic syringes. The syringes may leak or break, posing a risk to patient health during medical procedures.
Product
Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2992-2024·2024-09-18
Medline Medical Convenience Kits with Defective Syringes Recalled
Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and quality defects identified by an FDA Safety Alert. These defects may pose risks to patient safety during medical procedures.
Product
Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2986-2024·2024-09-18
Medline medical convenience kits recalled due to syringe quality defects
Medline is recalling multiple medical convenience kits worldwide that contain plastic syringes with defects that may leak or break, posing a risk to patient safety.
Product
Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ; 3) CARDIAC MINOR-LF, Pack Number DYNJ51939; 4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573; 5) PEDIATRIC EP PACKMH
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3000-2024·2024-09-18
Medline Tonsil and Adenoid Surgical Kits Recalled for Syringe Defects
Medline is recalling Tonsil & Adenoid surgical convenience kits containing defective plastic syringes. The kits may leak or break, posing risks to patient safety.
Product
Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2996-2024·2024-09-18
Medline Convenience Kits Recalled Due to Defective Plastic Syringes
Medline Industries is recalling multiple convenience kits containing plastic syringes with identified quality issues including leaks and breakage. These defects may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; 3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 4) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 5) BIOPSY TRAY, Pack Number D
Category
Medical Device
Distribution
0 states