Medline Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA-cleared specifications. Affected kits were distributed nationwide.
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 FDA classified this as a Class II recall. No reported illnesses, injuries, or deaths are mentioned in the source text. The hazard is regulatory non-compliance with an unapproved design change, which is a compliance-based rather than patient-harm issue per the available evidence.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select SKUs of 10mL polycarbonate colored syringes, including the ANGIOGRAM PACK-LF (DYNJ21574J) and JUDKINS PACK (DYNJ51126). The manufacturer identified unapproved design changes to these products that fall outside the scope of the design cleared by the FDA through the 510(k) process.
Approximately 113,843 kits have been distributed nationwide across 33 U.S. states (Alabama, Arizona, Arkansas, 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, and Wyoming) and to Barbados. Specific lot numbers are identified in the FDA recall notice.
Customers who have received these products should stop using them and contact Medline Industries, LP for further instructions. Healthcare providers and patients should not use the affected kits until guidance is provided by the manufacturer and FDA.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
- Manufacturer
- Medline Industries, LP
- 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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