CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report

Syringe Luer Lok 10cc-200/box Bd recalled by Mentor Texas

Mentor Texas is recalling Syringe Luer Lok 10cc-200/box Bd, distributed in California, Florida, Pennsylvania. The recall was initiated on 28 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBD 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 recalled1401 syringes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2614-2026
FDA event ID: 98981
Recalling firm: Mentor Texas, Coppell, TX
Classification: Class II
Status: Ongoing
Recall initiated: 28 Apr 2026
FDA classified: 26 Jun 2026
Reported: 8 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Syringes & Needles

Timeline

28 Apr 2026	Recall initiated by company
26 Jun 2026	Classified by FDA	+59 days
8 Jul 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

U.S.: CA, FL, and PA

California Florida Pennsylvania

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

U.S.: CA, FL, and PA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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