FDA recall, , Moderate risk
Mentor Texas Syringes
Expired syringes were distributed due to a distribution system control failure.
Summary by Recall Canary from the FDA notice
What happened
Mentor Texas LP of Coppell, Texas, began a recall on April 28, 2026, of 1401 syringes because a single lot of expired syringes were distributed due to a distribution system control failure.
The recalled product is the Syringe Luer LOK 10CC-200/Box BD, with Mentor Product Code B9604, and the FDA added it to its Enforcement Report and classified it on June 26, 2026, with the recall in the FDA's weekly enforcement report on July 8, 2026. The syringes were distributed in California, Florida and Pennsylvania.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your box affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Syringe Luer LOK 10CC-200/Box BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
- UDI-DI
- 30382903029952
- 00382903029952
- Lot code
- 8298877
Recall details
- Company began the recall
- Sold in
U.S.: California, Florida, and Pennsylvania
- Company
- Mentor Texas LPCoppell, Texas
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98981
- Recall number
- Z-2614-2026
- Quantity recalled
- 1401 syringes
All recalls from Mentor Texas LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
