Medline 10mL 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 clearance. The 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: This is an FDA Class II recall. No illnesses, injuries, or reported harms are mentioned in the source text. The hazard is a design deviation from the cleared specification, making this a moderate precautionary recall rather than a high-risk situation.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select SKUs of 10mL polycarbonate colored syringes. The recall affects approximately 113,843 kits with lot number 24ABO124 and UDI-DI 10195327458188 (model DYNJ54603B).
The firm identified unapproved design changes to the products that were made outside of the 510(k) clearance granted by the FDA. These changes were not part of the originally cleared design.
The affected kits have been distributed nationwide to all 50 states (AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY) and to Barbados.
Customers who have received these kits should stop using them and contact Medline Industries, LP or the FDA for instructions on return or disposal.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B
- Manufacturer
- Medline Industries, LP
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)
- DYNJ54603B UDI-DI 10195327458188 Lot 24ABO124
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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