Unrated Medical device recall · FDA · Published June 3, 2021

Axonics BULKAMID Urethral Bulking System Recall: Sterility Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2077-2021Medical device Axonics ›

Recall notice

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

Take action

Contact the company

Recalling firmAxonics Modulation Technologies, Inc.26 Technology Dr · Irvine, CA 92618-2380

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/62401-axonics-bulkamid-urethral-bulking-system-recall-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62401-axonics-bulkamid-urethral-bulking-system-recall-sterility-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2077-2021

Cite this page

“Axonics BULKAMID Urethral Bulking System Recall: Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62401-axonics-bulkamid-urethral-bulking-system-recall-sterility-risk. Based on FDA recall #Z-2077-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2077-2021%22&limit=1).

The FDA announced on June 3, 2021, that Axonics Modulation Technologies, Inc. is recalling BULKAMID Urethral Bulking System model #50050 containing Bulkamid Needles due to a lack of sterility assurance. The agency stated the recall addresses needles labeled as sterile that may not have been adequately sterilized.

How to tell if you have it

Brand: Axonics
Product: BULKAMID, URETHRAL BULKING SYSTEM model #50050 containing Bulkamid Needle
REF: 230651221C
Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA
Quantity: 2,702 units

The hazard

According to the FDA, the hazard is a lack of sterility assurance because the needle in the procedure pack labeled as sterile may not have been adequately sterilized.

Context

GovInfoNow's records show other recent recalls of similar products include Medline Convenience Kits Recall (2026-01-07), Medline Basic Nerve Block Tray Recall (2026-01-07), and Argon Medical Devices General Biospy Tray Recall (2026-06-01).

How to tell if you have this one

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.

Brand
Axonics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Review the model number and lot numbers on the packaging to determine if the product is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Jun 3, 2021Firm started the recall
Jul 15, 2021FDA classified it Class II
Jul 21, 2021Published in FDA’s Enforcement Report
Apr 20, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62401-axonics-bulkamid-urethral-bulking-system-recall-sterility-risk">Axonics BULKAMID Urethral Bulking System Recall: Sterility Risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-2077-2021 (June 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2077-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.