BULKAMID — Class II medical device recall Z-2077-2021
Terminated recall by Axonics Modulation Technologies, Inc., reported 2021-07-21, distributed nationwide. Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately steriliz
| Recall number | Z-2077-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Axonics Modulation Technologies, Inc., Irvine, CA, United States |
| Recall initiated | 2021-06-03 |
| Classified | 2021-07-15 |
| Reported by FDA | 2021-07-21 |
| Terminated | 2022-04-20 |
| Distributed | Nationwide (US) |
| Quantity | 2,702 units |
| Reason classes | labeling, sterility |
| Lot numbers | 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA |
| Model numbers | 230651221C, 50050 |
Product
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Reason for recall
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2077-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.