HNM Disposable Bipolar Ablators — Class II medical device recall Z-1154-2021
Ongoing recall by Bovie Medical Corporation, reported 2021-03-10, distributed nationwide. There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the cre
| Recall number | Z-1154-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bovie Medical Corporation, Clearwater, FL, United States |
| Recall initiated | 2021-02-01 |
| Classified | 2021-02-26 |
| Reported by FDA | 2021-03-10 |
| Distributed | Nationwide (US) |
| Quantity | 3,862 units |
| Reason classes | sterility |
| Lot numbers | 0418C, 0420H, 0518D, 0518H, 0618B, 0618D, 0818E, 0820H, 1017G, 1018J, 1018M, 1117B, 1117D, 1118J, 1119B, 1217B, 1218B |
| Model numbers | HNM-31-150365 |
Product
HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Reason for recall
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
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-1154-2021. 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.