Medline sterile saline bottles recalled for leaking at peel-foil interface
Medline Sterile 0.9% Normal Saline bottles are being recalled due to leaking at the peel-foil and bottle opening interface, which compromises product sterility. The recall affects approximately 2.5 million units distributed in the US, Panama, and Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a medical device with potential for compromised sterility and contamination risk, consistent with risk-of-harm products where injury has not yet been reported. No illnesses or injuries have been reported in the source text.
Plain-English summary
Medline Industries, LP is recalling Medline Sterile 0.9% Normal Saline, USP, 100mL bottles (REF RDI30296). The recall was initiated after it was identified that the bottles were leaking at the interface of the peel-foil and bottle opening.
The leaking defect compromises the sterility of the solution. Because this product is used for medical purposes where sterile conditions are essential, the potential for contamination poses a risk to patients and healthcare facilities.
The recall affects 2,519,991 units that were distributed worldwide, including throughout the United States, Panama, and Canada. The recalled product is identified by specific lot numbers, including 23DJA038, 23DJA070, 23DJA114, and others.
Consumers and healthcare professionals who have bottles from the affected lot numbers should discontinue use immediately. Affected parties should contact Medline Industries for information on replacement, return, or proper disposal of the product.
The recalled product
- Product
- Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leaking
- contamination-risk
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.
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