The Recall Desk
ModerateFDA (Devices)·Z-1706-2025·Announced 2025-05-07

Medline Sterile 0.9% Normal Saline 100mL bottles recalled for leaks

Medline Sterile 0.9% Normal Saline 100mL bottles are being recalled because they may leak at the interface where the peel-foil meets the bottle opening. The bottles were distributed nationwide in the US and in Panama and Canada.

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 for a medical device with a structural/packaging defect (leaking bottles). The source text does not report any illnesses, injuries, or actual harm from the leak, making it a precautionary recall based on a potential risk.

Plain-English summary

Medline Industries, LP is recalling Medline Sterile 0.9% Normal Saline, USP, 100mL (REF RDI30296) because the bottles were identified as leaking at the interface of the peel-foil and bottle opening. The affected product includes 2,519,991 units with specific lot numbers ranging from 23DJA038 through 24KJA148.

The recalled product was distributed worldwide, including US nationwide distribution and shipments to Panama and Canada. Affected consumers and healthcare providers should not use the product and should contact Medline Industries for further instructions regarding the recalled bottles.

The recalled product

Product
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • leaking-container

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 (20)

  • UDI/DI 10884389338247 (EA) 10884389338230 (CS)
  • Lot Numbers: 23DJA038
  • 23DJA070
  • 23DJA114
  • 23EJA057
  • 23EJA128
  • 23EJA144
  • 23FJA110
  • 23GJA041
  • 23GJA118
  • 23GJA132
  • 23HJA033
  • 23IJA045
  • 23IJA052
  • 23IJA102
  • 23JJA103
  • 23JJA119
  • 23JJA144
  • 23LJA114
  • 24AJA025

Distribution

Distributed nationwide across the United States.