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Syringe Luer Lok 10cc-200/Box recallZ-2614-2026 · Mentor Texas LP · initiated Apr 28, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Mentor Texas LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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 [email protected] 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 [email protected]. " Returned to Mentor Coppell Logistics Center, 555 Airline Dr Suite 200 Coppell, TX 75019. For questions - contact Mentor 1 800-525-0245 or email [email protected].

Recall details

Recall number
Z-2614-2026
Status
Open, Classified
Initiated by the company
Apr 28, 2026
Posted by the FDA
Jun 26, 2026
Recalling firm
Mentor Texas LP
Quantity
1401 syringes
Product code
FMF
FDA submissions
K110771
Distribution
U.S.: CA, FL, and PA

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

76 devices cleared under K110771 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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