The Recall Desk
ModerateFDA (Devices)·Z-1709-2025·Announced 2025-05-07

Medline Sterile Water and Saline Bottles Recalled for Leaking Seals

Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The source text does not report any illnesses, injuries, or hospitalizations—only a product defect (leaking seals). Per the rubric, Class II without hospitalization reports and without reported illness falls into the Moderate category.

Plain-English summary

Medline Industries, LP is recalling six procedure kits containing Sterile Water and Sterile 0.9% Normal Saline bottles. The bottles have been identified as leaking at the interface where the peel-foil seal meets the bottle opening.

The affected products include: STERILE PREP KIT (REF DYNDA1359A), STRL EK SINGLE PACK (REF DYNDA1360B), SHEATH REMOVAL TRAY (REF DYNDC1311C), SENSITIVE SKIN WEEKLY VAD (REF DYNDC3185), NURSING SKILLS (REF EDUC05015A), and NURSING SUPPLY BAG (REF EDUC1024A). A total of 822 units have been distributed worldwide, including throughout the United States, Panama, and Canada. Specific lot numbers are available through the FDA.

Healthcare facilities and individuals who have received these kits should stop using affected bottles and contact Medline Industries or their healthcare provider with questions. The FDA is monitoring the situation.

The recalled product

Product
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC102
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Sterile Solutions / Procedure Kits
Hazard
  • leaking-seal
  • sterile-integrity

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • 1) REF DYNDA1359A: UDI/DI 10195327417734 (EA) 40195327417735 (CS)
  • Lot Numbers: 23KBW508
  • 2) REF DYNDA1360B: UDI/DI 10889942903863 (EA) 40889942903864 (CS)
  • Lot Numbers: 23KBB406
  • 3) REF DYNDC1311C: UDI/DI 10080196151561 (EA) 40080196151562 (CS)
  • Lot Numbers: 23KBX338
  • 4) REF DYNDC3185: UDI/DI 10195327034108 (EA) 40195327034109 (CS)
  • Lot Numbers: 23KBX632
  • 5) REF EDUC05015A: UDI/DI 10193489849035 (EA) 40193489849036 (CS)
  • Lot Numbers: 23LDA746
  • 23LDA814
  • 23LDA218
  • 6) REF EDUC1024A: UDI/DI 10195327493165 (EA) 40195327493166 (CS)
  • Lot Numbers: 23LDA281
  • 23KDA001.

Distribution

Distributed nationwide across the United States.

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