Medical Device

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF

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

Brand / Firm

Product

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62858B TAVR JUDKINS PACK DYNJ51127B

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 →