Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products underwent unapproved design changes outside of FDA clearance.
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: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or known harms from the unapproved design changes, making this a precautionary recall based on manufacturing/regulatory noncompliance rather than an actual safety incident.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes due to unapproved design changes made to the products outside of the 510(k) clearance granted by the FDA. The affected kits include model numbers DYNJ51124B (DR G'S BREAST PACK), DYNJ0341174D (LIPO SUPPLEMENT PACK-LF), DYNJ66746 (PLASTIC PACK), and DYNJ85702.
Approximately 113,843 kits have been 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.
Consumers and healthcare providers who have received these products should contact Medline Industries, LP with any questions or to arrange for return or replacement of the affected kits.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S BREAST PACK DYNJ51124B LIPO SUPPLEMENT PACK-LF DYNJ0341174D PLASTIC PACK DYNJ66746 DYNJ85702
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 113,843
Distribution
Part of a larger recall action
This product is one of 16 recalled by Medline Industries, LP 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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