SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
Summary
The FDA issued a Class II for SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B96 by Mentor Texas LP. Reason: A single lot of expired syringes were distributed due to a distribution system control failure..
Details
Source
Device Recall
External ID
Z-2614-2026
Action Date
2026-07-08
Status
Ongoing
Category
device
Product Description
SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
Lot/Code Info: 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
Quantity Affected: 1401 syringes
Reason for Recall
A single lot of expired syringes were distributed due to a distribution system control failure.
Distribution
U.S.: CA, FL, and PA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-28
Company
Coppell, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 186 device recalls issued in the same week, part of 534 device-related FDA actions this month.
Mentor Texas LP has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mentor Texas LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mentor Texas LP have FDA actions?
Mentor Texas LP has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2614-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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