Urethral bulking system needles recalled due to sterility assurance failure
Axonics is recalling BULKAMID urethral bulking system needles that may not have been adequately sterilized despite sterile labeling. Unsterilized surgical needles pose infection risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving sterility assurance failure in a surgical needle component. While no illnesses or injuries have been reported in the source text, the use of inadequately sterilized surgical needles presents a direct risk of infection. This risk-of-harm product where injury has not yet been reported meets the criteria for High severity.
Plain-English summary
Axonics Modulation Technologies, Inc. is recalling the BULKAMID Urethral Bulking System, model 50050, specifically the Bulkamid Needle component (Reference 230651221C). The recall affects 2,702 units distributed nationwide in the United States.
The needles in the affected procedure packs are labeled as sterile but may not have been adequately sterilized. This represents a failure in sterility assurance for a surgical medical device component that comes into contact with patient tissue during urological procedures.
Patients who have received treatment using affected BULKAMID system needles may be at risk. Unsterilized or inadequately sterilized surgical needles can introduce bacteria and other microorganisms, potentially causing post-procedure infections.
Patients with concerns about their treatment should contact their healthcare provider. Healthcare providers with affected product should cease use and contact Axonics Modulation Technologies, Inc. for return instructions.
The recalled product
- Product
- BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
- Manufacturer
- Axonics Modulation Technologies, Inc.
- Affected units
- 2,702
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot numbers: 19F0901AA
- 19F0902AA
- 19F0903AA
- 19F0904AA
- 19F0905AA
- 19F0906AA
Distribution
Distributed nationwide across the United States.
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