Recall Z-1834-2026— Medline Industries, LP
Class II · Ongoing
Class II FDA medical device recall by Medline Industries, LP, initiated 2026-02-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Number: DYNJ53369C; 7) ANGIO PACK, Model Number: DYNJ53591A; 8) ANGIOGRAPHIC PACK, Model Number: DYNJ57516; 9) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ58722A; 10) ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; 11) CEREBRAL ANGIOGRAM, Model Number: DYNJ67876; 12) CSU CATH MANIFOLD KIT, Model Number: VASC1170A. Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded..
- Recalling firm
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-02-25
- Firm location
- Northfield, IL, United States
Product description
Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Number: DYNJ53369C; 7) ANGIO PACK, Model Number: DYNJ53591A; 8) ANGIOGRAPHIC PACK, Model Number: DYNJ57516; 9) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ58722A; 10) ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; 11) CEREBRAL ANGIOGRAM, Model Number: DYNJ67876; 12) CSU CATH MANIFOLD KIT, Model Number: VASC1170A
Reason for recall
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Data sourced from openFDA. This site is unofficial and independent of the FDA.