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.

401–425 of 717

SevereFDA (Drugs)·D-0938-2018·2018-07-25
Avella Recalls Morphine Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley, Inc. is recalling 1,500 bags of Morphine 1 mg/mL due to potential bag leakage and lack of assurance of sterility.
Product
MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0958-2018·2018-07-25
Avella Recalls NORepiNEPHrine 16 Bags Due to Sterility Concerns
Avella of Deer Valley, Inc. is recalling 520 bags of NORepiNEPHrine 16 injection due to potential bag leakage and lack of assurance of sterility.
Product
NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-834-25
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2507-2018·2018-07-25
Medtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
Medtronic is recalling Tri-Staple 2.0 Black Intelligent Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Product
Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0944-2018·2018-07-25
Avella Recalls Fentanyl and Bupivacaine Cassettes Due to Sterility Concerns
Avella of Deer Valley, Inc. is recalling 15 cassettes of fentanyl and bupivacaine due to potential bag leakage and lack of sterility assurance.
Product
fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9% Sodium Chloride, USP QS 250 mL. Volume: 250mL. Single dose Cassette. For: Methodist St. John Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-250-8
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0942-2018·2018-07-25
Avella Recalls Ropivacaine Infusion Bags Due to Sterility Concerns
Avella of Deer Valley, Inc. is recalling 20 bags of 0.2% Ropivacaine infusion cassettes due to potential leakage that compromises sterility.
Product
0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0948-2018·2018-07-25
Avella Recalls Heparin Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley, Inc. is recalling 40 bags of Heparin 1,000 Units in NS 250mL due to potential leakage that compromises sterility.
Product
HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC 42852-747-25
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0934-2018·2018-07-25
Avella Recalls Heparin Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley is recalling 240 bags of Heparin 25,000 Units in 5% Dextrose due to potential bag leakage and lack of sterility assurance.
Product
HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix AZ 85085. NDC 42852-729-25
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0905-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling 196 bags of Phenylephrine HCL 80mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.
Product
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0898-2018·2018-07-11
SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.
Product
Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0903-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling 400 bags of Phenylephrine HCL 20 mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.
Product
Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0894-2018·2018-07-11
SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Morphine Sulfate 1 mg/mL syringes due to a potential for leakage that compromises sterility.
Product
Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0895-2018·2018-07-11
SCA Pharmaceuticals Recalls Fentanyl Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling 492 bags of Fentanyl admixture due to a potential for leakage that compromises sterility.
Product
Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0897-2018·2018-07-11
SCA Pharmaceuticals Recalls Diltiazem HCL Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Diltiazem HCL sterile admixtures due to a potential for leakage that compromises sterility.
Product
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0902-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL due to potential leakage that compromises sterility.
Product
Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0901-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL due to a potential for leakage that compromises sterility.
Product
Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0899-2018·2018-07-11
SCA Pharmaceuticals Recalls Norepinephrine Bitartrate Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate 8 mg bags due to a potential for leakage that compromises sterility.
Product
Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0904-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling specific lots of Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL bags due to a potential for leakage that compromises sterility.
Product
Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0900-2018·2018-07-11
SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.
Product
Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0881-2018·2018-06-27
ICU Medical Recalls 0.45% Sodium Chloride Injection Bags Due to Sterility Concerns
ICU Medical Inc. is recalling 88,960 bags of 0.45% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.
Product
0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0884-2018·2018-06-27
ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns
ICU Medical Inc is recalling 0.9% Sodium Chloride Injection bags because they may leak, compromising sterility. The recall covers lots distributed nationwide and in Canada.
Product
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0883-2018·2018-06-27
ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns
ICU Medical is recalling 525,984 bags of 0.9% Sodium Chloride Injection due to potential leaks that compromise sterility. The product was distributed nationwide and in Canada.
Product
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0882-2018·2018-06-27
ICU Medical Recalls Sodium Chloride Injection Bags Due to Sterility Concerns
ICU Medical is recalling 941,496 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.
Product
0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0885-2018·2018-06-27
ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns
ICU Medical is recalling 5% Dextrose Injection bags because they may leak, compromising sterility. The recall covers 267,288 bags distributed nationwide and in Canada.
Product
5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1830-2018·2018-05-23
COVIDIEN Medtronic Recalls Endo GIA Staplers for Missing Sled Component
COVIDIEN Medtronic is recalling approximately 171,271 Endo GIA universal staplers because a missing sled component may prevent proper staple deployment. This defect can lead to bleeding or leakage of luminal contents during surgery.
Product
(1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII) (2) BOX LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI (item number: LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1817-2018·2018-05-23
Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component
Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, risking bleeding or leakage.
Product
Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( Item Code 030454) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two,
Category
Medical Device
Distribution
Distributed nationwide