The Recall Desk

Hazard

Product Leakage recalls

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

What the numbers show

Total
11
Critical
0
Severe
3
Most recent
2026-04-29

Of the 11 product 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 3 (27%) 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 product 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.

1–11 of 11

  • SevereFDA (Drugs)·D-0495-2026·2026-04-29

    Sterile Water for Injection bags recalled due to sterility concerns

    B. Braun Medical Inc. is recalling Sterile Water for Injection USP 3000 mL bags (24,928 units) distributed nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port.

    Product
    STERILE WATER — STERILE WATER (WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0399-2025·2025-05-07

    Nicardipine Hydrochloride Injection Recalled for Potential Sterility Loss

    American Regent, Inc. is recalling certain lots of Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects 7,249 cartons distributed nationwide.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0398-2025·2025-05-07

    Nicardipine Hydrochloride Injection Recalled for Potential Sterility Issues

    American Regent, Inc. is recalling Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects multiple lots distributed nationwide.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3144-2024·2024-09-25

    Anesthesia Extension Sets recalled due to potential Spin Lock connector leakage

    B. Braun Medical is recalling 19,050 AET36 Anesthesia Extension Sets due to potential product leakage from the Spin Lock Connector caused by excess solvent migration during manufacturing.

    Product
    AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0628-2024·2024-08-14

    PEG-3350 Oral Solution Recalled for Defective Non-Sealed Pouches

    A PEG-3350 oral solution is being recalled nationwide due to defective pouches that may not be properly sealed, risking product leakage. The recall affects 13,200 cartons with lot number S300542.

    Product
    PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID — PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID (PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0364-2024·2024-03-13

    Clindamycin Phosphate Topical Solution recalled for defective container leakage

    Contract Pharmaceuticals Limited Canada is recalling 45,875 bottles of Clindamycin Phosphate Topical Solution USP 1% due to defective containers that leak slowly. The product was distributed nationwide in the U.S. and Puerto Rico.

    Product
    Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1140-2023·2023-09-06

    DIANEAL Low Calcium peritoneal dialysis solution recalled for potential sterility compromise

    Baxter Healthcare is recalling DIANEAL Low Calcium With Dextrose peritoneal dialysis solution due to potential leaks from the Luer component that could compromise sterility. The FDA classified this as a Class II recall.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1756-2022·2022-09-28

    BD MaxGuard Administration Set Recalled for Incorrect Expiration Date Labels

    BD MaxGuard Drop Administration set labels incorrectly list expiration year 2027 instead of 2025. Use of expired product risks compromised integrity, potential leaks, and patient or worker infection.

    Product
    BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1759-2022·2022-09-28

    BD MaxGuard Extension Set Recalled for Incorrect Expiration Year

    CAREFUSION's BD MaxGuard Extension Set is being recalled because product labels incorrectly list expiration year 2027 instead of 2025. Using expired product may compromise integrity, potentially causing leaks and infection risk.

    Product
    BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Drugs)·D-0278-2022·2021-12-22

    Diclofenac Sodium Topical Solution Recalled for Leaking Bottles

    Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution 1.5% in 150 mL bottles due to container defects that cause leaking. The affected lot was distributed to physician offices in Connecticut, Florida, and Kansas.

    Product
    Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
    Category
    Drug
    Distribution
    3 states