Medline Sterile Water and Saline Bottles Recalled for Leaking Peel-Foil Seals
Medline procedure kits containing Sterile Water and Sterile 0.9% Normal Saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 containers). The hazard is a labeling/packaging defect rather than a contamination or high-risk pathogen, making this a moderate-severity precautionary recall.
Plain-English summary
Medline Industries, LP is recalling Medline procedure kits labeled as REDDY JOINT BATH (Reference MMJB001A) due to leaking in the Sterile Water and Sterile 0.9% Normal Saline bottles. The leaks occur at the interface where the peel-foil meets the bottle opening.
The recalled kits have been distributed worldwide, including throughout the United States, Panama, and Canada. A total of 2220 units are affected. The lot numbers involved are 24BBJ082, 23KBH046, and 23JBD137. The UDI/DI codes are 10195327514877 (EA) and 40195327514878 (CS).
Consumers who have these kits should stop using them and contact Medline Industries or their healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 2,220
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 (4)
- UDI/DI 10195327514877 (EA) 40195327514878 (CS)
- Lot Numbers: 24BBJ082
- 23KBH046
- 23JBD137
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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