Medical Device Convenience Kits with 10mL Polycarbonate Syringes Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA-cleared specifications. The recall affects approximately 113,843 kits 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall involving medical devices with unapproved design changes outside cleared specifications. Per the rubric, FDA Class II recalls are typically scored 4 (Severe) when they represent a significant risk to patient safety, as design deviations from cleared specifications warrant heightened concern in sterile/injectable devices.
Plain-English summary
Medline Industries, LP is recalling multiple convenience kits that contain select SKUs of 10mL polycarbonate colored syringes. The affected kits include Cataract Full Body, Major Vascular Pack, Minimally Invasive Pack-LF, Pediatric Cath Angio Pack, Peripheral Arteriogram Rad, Posterior Spine Pack-LF, Upper Extremity, and Visceral Angiogram Pack-LF kits.
The manufacturer identified unapproved design changes to these products that were made outside of the design cleared by the FDA through the 510(k) process. These products were not part of the original recall notification (RES 98601).
Approximately 113,843 kits have been distributed nationwide across the United States, including 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, Wyoming, and Barbados. Specific lot numbers and UDI-DI codes are available in the detailed product information.
Consumers and healthcare facilities should contact Medline Industries regarding their use of these kits and any necessary corrective actions.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD…
- 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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