Medical Device

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK

Recall date: 2026-07-01 · Source: FDA_DEVICE

Brand / Firm

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 DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L

Reason for recall

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Units affected

113,843 kits

Description

View official recall notice →