Bovie Medical Recalls HNM Disposable Bipolar Ablators Due to Packaging Defect
Bovie Medical Corporation is recalling 3,862 HNM Disposable Bipolar Ablators because pinholes in the sterile packaging may compromise the barrier.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential breach of the sterile barrier, which is a significant quality issue but does not involve reported injuries or high-risk pathogens, fitting the Moderate criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Bovie Medical Corporation is recalling 3,862 units of HNM Disposable Bipolar Ablators. These medical devices are intended for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. The recall involves specific catalog numbers and lots, including HNM-31-150365, HNM-31-150367, and HNM-31-150368.
The recall was initiated due to a potential breach of the sterile packaging barrier. This issue is caused by the development of pinholes at the crease of the double-folded edge of the package configuration. The affected units were distributed nationwide in the states of California and Florida.
Healthcare facilities and consumers should stop using the affected devices and contact Bovie Medical Corporation for further instructions or a return.
The recalled product
- Product
- HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
- Manufacturer
- Bovie Medical Corporation
- Affected units
- 3,862
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 (18)
- Catalog Numbers HNM-31-150365 (lots 1017G
- 1117B
- 1217B
- 0418C
- 0518D
- 0518H
- 0618B
- 0618D
- 0818E
- 1018J
- 1018M
- 1118J
- 1218B
- 1119B
- 0420H
- 0820H)
- HNM-31-150367 (lot 1117D)
- HNM-31-150368 (lot 1117D).
Distribution
Part of a larger recall action
This product is one of 3 recalled by Bovie Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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