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FDAJune 3, 2021device

BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized

What to do

FDA enforcement status: Terminated

Brands named

axonics modulation technologiesaxonicsaxonics modulation

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476 — Recall Details · AllClear