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Recall Observatory FDA recall evidence

Device product

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

Z-2614-2026

April 28, 2026

Class II

Product summary

Firm
Mentor Texas LP
Event
Event 98981
Status
Ongoing
Classification
Class II
Quantity
1401 syringes
Official record key
device-enforcement:Z-2614-2026

Official wording

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

Code information: 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 pattern: U.S.: CA, FL, and PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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