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

FDA device recall Z-2614-2026 · posted 2026-06-26 · Open, Classified

Recall details

Recalling firm

Mentor Texas LP

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

FMF

Quantity affected

1401 syringes

Distribution

U.S.: CA, FL, and PA

Date initiated

2026-04-28

Date posted

2026-06-26

Location

Coppell, TX

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