Official recall notice
FDA DeviceClass IINotable
FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TR
- Recall date
- 2026-07-01
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Product description
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Affected products
DYNJ54603B UDI-DI 10195327458188 Lot 24ABO124