Axonics recalls BULKAMID urethral bulking system model 50050 with potential sterility issues in needle components. Affected units may not have been properly sterilized, risking infection during medical procedures.
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Axonics is recalling a specific urethral bulking system model due to potential sterility issues in the needle components. This could lead to infections if used in medical procedures without proper sterilization.
The needles in the procedure pack are labeled as sterile but may not have been adequately sterilized. This could lead to infections during medical procedures if the product is used without proper sterilization.
Patients who received the recalled BULKAMID urethral bulking system model #50050 from Axonics. Medical professionals using the product for procedures are at risk if the needles were not properly sterilized.
Check for the model number 50050 on the product packaging. The specific lot numbers 19F0901AA through 19F0906AA are also affected. The product contains the Bulkamid Needle with reference number 230651221C.
Review the model number and lot numbers on the packaging to determine if the product is affected.
The product may not have been properly sterilized, so it is not safe to use without checking if it is in the recalled lot numbers.
The official recall notice does not specify a remedy or action for affected products.
Check for the model number 50050 and lot numbers 19F0901AA through 19F0906AA on the packaging.
We’ve drafted a message you can send Axonics to request your refund or repair — edit it as you like.
Subject: Recall Z-2077-2021 — Axonics Axonics Hello, I own a Axonics that is covered by recall Z-2077-2021 from Axonics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
