Official recall notice
FDA DeviceClass IINotable
FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PAC
- Recall date
- 2026-04-29
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Unapproved design changes to the products outside of the 510(k) clearance.
Recommended action
What to do
270,311 total
Product description
Unapproved design changes to the products outside of the 510(k) clearance.