Mentor Texas LP recalls SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 S…

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

On 04/28/2026, the firm sent an "URGENT: MEDCIAL DEVICE RECALL (REMOVAL)" letter to customers informing them that a limited quantity of BD" 10ml Syringe Luer-Lok" Tip (lot 8298877) was distributed after the labeled expiration date (September 30, 2023). Customers are instructed to: 1. Examine inventory immediately to determine if you have products on hand. Stop/discontinue use of the products, search any additional area where the affected products may be used and quarantine such product(s). Maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant personnel, operating room or materials management personnel, or anyone in your facility who needs to be informed. If any product have been forwarded to another facility, contact that facility to arrange return. 3. Complete the Business Reply Form confirming receipt of this notice and email it to RA-Mentor_Recalls@its.jnj.com within three (3) business days. Return the BRF even if you do not have product subject to this recall. 4. Customers must return product no later than 08/07/2026 to Mentor. A credit will be issued for the returned product. 5. To return product subject to this recall: " BD" 10ml Syringe Luer-Lok" Tip, BD" Product Code: 302995; Mentor" Part Number: B9604 and Lot Number: 8298877. Refer to Attachment 1 on how to identify the 10ml Syringe. " Photocopy the completed BRF, place it in a return box (if necessary) with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Mentor will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Mentor at 1 800-525-0245 or emailing RA-Mentor_Recalls@its.jnj.com. " Returned to Mentor Coppell Logistics Center, 555 Airline Dr Suite 200 Coppell, TX 75019. For questions - contact Mentor 1 800-525-0245 or email RA-Mentor_Recalls@its.jnj.com.

• FDA enforcement recordOfficial FDA database entry for Z-2614-2026
• FDA 510(k) clearance · K110771The device's official FDA premarket clearance record
• FDA device classification · FMFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5860The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Mentor Texas LPSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.