Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance requirements.
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: FDA classification is Class II. The source text contains no reports of hospitalization, injury, or illness. The hazard is an unapproved design change, which does not meet the thresholds for High (reported illness/injury) or above per the rubric.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes, identified by the kit number DYNJ85723. The recall affects approximately 113,843 kits that were distributed nationwide across the United States, including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin, Wyoming, and Barbados.
The manufacturer identified unapproved design changes to the products that were made outside of the 510(k) clearance granted by the FDA. These products were not initially reported in a related recall (RES 98601).
Patients and healthcare providers currently using or possessing these kits should discontinue use and contact Medline Industries, LP or the FDA for instructions on how to proceed. Healthcare facilities should review their inventory and isolate affected units to prevent further distribution or use.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Syringes
- Hazard
- unapproved-design-change
- regulatory-non-compliance
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 (1)
- DYNJ85723 UDI-DI 10195327538491 Lot 24ABO130
Distribution
Distributed nationwide across the United States.
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