Recall Z-1876-2026— 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 JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF DYNJ0220880V, DYNJ30077D CATH LAB ANGIO PACK-LF DYNJ0545064X CATH LAB PACK DYNJ39057C FEMORAL ANGIOGRAPY SET UP DYNJ61015B RAD-ANGIO PACK DYNJ47710C SURGERY ANGIO PACK-LF PHS677784013A. 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 JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF DYNJ0220880V, DYNJ30077D CATH LAB ANGIO PACK-LF DYNJ0545064X CATH LAB PACK DYNJ39057C FEMORAL ANGIOGRAPY SET UP DYNJ61015B RAD-ANGIO PACK DYNJ47710C SURGERY ANGIO PACK-LF PHS677784013A
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.