Class 2 Device Recall BD 10ml Syringe LuerLok Tip

• Date Initiated by Firm: April 28, 2026
• Date Posted: June 26, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2614-2026
• Recall Event ID: 98981
• 510(K)Number: K110771
• Product Classification: Syringe, piston - Product Code FMF
• Product: SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
• 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
• FEI Number: 3006165545
• Recalling Firm/ Manufacturer: Mentor Texas LP; 555 Airline Dr; Coppell TX 75019-4660
• For Additional Information Contact: 908-218-3392
• Manufacturer Reason for Recall: A single lot of expired syringes were distributed due to a distribution system control failure.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 1401 syringes
• Distribution: U.S.: CA, FL, and PA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FMF