Bovie Medical recalls HNM Disposable Bipolar Ablators with potential pinholes in sterile packaging that could breach sterility during surgery. Affected units have specific catalog numbers and lots.
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.
Bovie Medical is recalling disposable bipolar ablation devices used in arthroscopic surgery because their packaging might develop pinholes, risking contamination. This could lead to infections if the device is used without proper sterility.
The packaging may develop pinholes at the folded edge, potentially breaching the sterile barrier. If the device is used without proper sterility, it could lead to infections during surgery.
Surgical teams using the HNM Disposable Bipolar Ablators for arthroscopic procedures are most at risk. Patients and medical staff who have the specific catalog numbers and lots listed are affected.
Check for catalog numbers HNM-31-150365 (lots 1017G, 1117B, etc.) or HNM-31-150367 (lot 1117D) or HNM-31-150368 (lot 1117D). These devices were sold with specific production lots.
Look for the catalog numbers and lots listed in the recall notice to confirm if your device is affected.
The packaging may develop pinholes at the folded edge, potentially breaching the sterile barrier and risking contamination during surgery.
Check the catalog numbers and lots listed in the recall notice to see if your device is affected. If it is, you should contact Bovie Medical for further instructions.
Yes. Affected units include catalog numbers HNM-31-150365 (lots 1017G, 1117B, 1217B, 0418C, 0518D, 0518H, 0618B, 0618D, 0818E, 1018J, 1018M, 1118J, 1218B, 1119B, 0420H, 0820H) and HNM-31-150367 (lot 1117D) and HNM-31-150368 (lot 1117D).
We’ve drafted a message you can send Bovie to request your refund or repair — edit it as you like.
Subject: Recall Z-1154-2021 — Bovie Bovie Hello, I own a Bovie that is covered by recall Z-1154-2021 from Bovie. 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.
