The Recall Desk
ModerateFDA (Devices)·Z-1713-2025·Announced 2025-05-07

Medline Sterile Water and Saline Bottles Recalled for Leaking

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 hazard is a sterility/contamination concern from leaking saline and water bottles, but the source text does not report any illnesses, injuries, or hospitalizations. The recall is precautionary in nature based on a product defect.

Plain-English summary

Medline Industries, LP is recalling Medline procedure kits labeled as OL OCULAR (REF DYNJ906183K, UDI/DI 10195327385521 and 40195327385522, Lot Number 23LME299) due to leaking at the interface of the peel-foil and bottle opening in the included Sterile Water and Sterile 0.9% Normal Saline bottles.

The affected kits were distributed worldwide, including nationwide throughout the United States and to Panama and Canada. A total of 30 units were recalled.

Consumers who have received these kits should stop using the affected Sterile Water and Sterile 0.9% Normal Saline bottles immediately. Leaking may compromise the sterility of the contents and the integrity of the product. Anyone with questions about the recall should contact Medline Industries or their healthcare provider.

The recalled product

Product
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • leaking
  • sterility-compromise

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 (2)

  • UDI/DI 10195327385521 (EA)40195327385522 (CS)
  • Lot Numbers: 23LME299

Distribution

Distributed nationwide across the United States.