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
- Affected units
- 30
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.
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.
See all 10 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighAlcohol prep pads recalled for isopropyl alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- CriticalReprocessed electrophysiology catheters recalled over small residual particulates in specific lots
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · leaking
See all →- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Single Spike Tube Set Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighBD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk
FDA (Devices) · 2025-06-18
- HighMedline Sterile Water and Saline Bottles Leaking at Seal Interface
FDA (Devices) · 2025-05-07