Z-2614-2026 Class II Ongoing

Recalled by Mentor Texas LP — Coppell, TX

FDA device recall Z-2614-2026 was initiated by Mentor Texas LP on April 28, 2026 and is designated Class II. Reason for recall: A single lot of expired syringes were distributed due to a distribution system control failure. The recall status is ongoing. Affected quantity: 1401 syringes.

Recall Details

Product Type
Devices
Report Date
July 8, 2026
Initiation Date
April 28, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1401 syringes

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.

Distribution Pattern

U.S.: CA, FL, and PA

Code Information

BD Product Code: 302995 Mentor Product Code: B9604 Sales Unit Box UDI-DI/GTIN code: 30382903029952 Individual Unit UDI-DI/GTIN code: 00382903029952 Lot Number: 8298877