Recall Z-2614-2026— Mentor Texas LP

Name: FDA recall Z-2614-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-28

Class II · Ongoing

Class II FDA medical device recall by Mentor Texas LP, initiated 2026-04-28. It names one FDA 510(k) clearance: K110771. Product: SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston. Reason: A single lot of expired syringes were distributed due to a distribution system control failure..

Recalling firm: Mentor Texas LP
Classification: Class II
Status: Ongoing
Initiated: 2026-04-28
Firm location: Coppell, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K110771 — BD SINGLE USE, HYPODERMIC SYRINGEBecton, Dickinson and Company·cleared 2011-05-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston

Reason for recall

A single lot of expired syringes were distributed due to a distribution system control failure.

Data sourced from openFDA. This site is unofficial and independent of the FDA.