Recall Z-1833-2026— Medline Industries, LP

Name: FDA recall Z-1833-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-25

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) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A. 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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded..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) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A

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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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.