Official recall notice
FDA DeviceClass IINotable
Convenience kits Recall (Jul 2026) – Medline Industries
Product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
- 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
SAMP0551 UDI-DI 10195327268503 Lots 22JBG593 22JBJ361