Z-2614-2026Class II

Syringe Luer Lok 10Cc-200/Box Bd

Name: Z-2614-2026 Syringe Luer Lok 10Cc-200/Box Bd
Creator: Mentor Texas LP
Published: 2026-04-28
License: https://open.fda.gov/license/

Mentor / initiated 2026-04-28 / Open, Classified / root cause: manufacturing process

FDA source

Mentor Texas LP began a recall of SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston on 2026-04-28. FDA classified it as Class II and gives the reason as "A single lot of expired syringes were distributed due to a distribution system control failure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2614-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-28
Posted: 2026-06-26
Recalling firm: Mentor
Product: SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
Product code: FMF Syringe, Piston
Reason for recall: A single lot of expired syringes were distributed due to a distribution system control failure.
Root cause tag: manufacturing process
FDA root 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 [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].
Quantity in commerce: 1401 syringes
Distribution: U.S.: CA, FL, and PA
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2614-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2614-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-26

Product code FMF

K110771Class IIBd Single Use, Hypodermic SyringeBecton, Dickinson and Company / cleared 2011-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)