FDA Medical devices recall ·
SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code:… recall
- Recall number
- Z-2614-2026
- Date
- (initiated April 28, 2026)
- Company / brand
- Mentor Texas, LP.
555 Airline Dr, Coppell, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1401 syringes
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
Why was it recalled?
A single lot of expired syringes were distributed due to a distribution system control failure.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
U.S.: CA, FL, and PA
States: California Florida Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2614-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.