Class II U.S. Food and Drug Administration

Syringe Luer LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product recall: A single lot of expired syringes were distributed due to a distribution

Recall published 4 months ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: A single lot of expired syringes were distributed due to a distribution system control failure.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2614-2026
Published
July 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Mentor Texas LP
Product type
Medical devices
Units affected
1401 syringes
Distribution
California, Florida, Pennsylvania
Made in
United States
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
UPC codes
30382903029952, 00382903029952

Products covered by this recall

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

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 30382903029952
  • 00382903029952

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 8298877 — 1401 syringes

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Mentor Texas LP — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Mentor Texas LP — 555 Airline Dr, Coppell, TX, 75019-4660

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Mentor Texas LP medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 30382903029952, 00382903029952; lot code 8298877 — 1401 syringes. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists California, Florida, Pennsylvania.

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