Recall Z-1879-2026— Medline Industries, LP
Class II · Ongoing
Class II FDA medical device recall by Medline Industries, LP, initiated 2026-02-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B. Reason: Unapproved design changes to the products outside of the 510(k) clearance..
- Recalling firm
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-02-27
- Firm location
- Northfield, IL, United States
Product description
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
Reason for recall
Unapproved design changes to the products outside of the 510(k) clearance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.