Medline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the manufacturer made unapproved design changes not cleared by the FDA.
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. The source text does not report any illnesses, injuries, or deaths, and the hazard is that design changes were made without FDA clearance—a regulatory/documentation issue rather than an immediate safety threat. No adverse health consequences are reported or explicitly implied.
Plain-English summary
Medline Industries, LP is recalling convenience kits that contain select SKUs of 10mL polycarbonate colored syringes, including central line trays, fistulagram packs, fistulogram packs, invasive line insertion kits, non-vascular packs, and vascular access packs. A total of 113,843 kits are affected by this recall.
The firm identified unapproved design changes to the products that were made outside of the FDA 510(k) clearance process. These design modifications were not initially reported in the related FDA recall (RES 98601).
The affected kits have been distributed nationwide to the following 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.
Consumers and healthcare facilities should stop use and contact Medline Industries for instructions on return or replacement of the affected convenience kits.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ47899A INVASIVE LINE INSERTION DYNJ44123B NON VASCULAR PACK DYNJ68037A VASCULAR…
- Manufacturer
- Medline Industries, LP
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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