FDA (Devices) recall action 87274
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Bovie Medical Corporation is recalling Velocity Disposable Bipolar Ablators because pinholes in the sterile packaging may compromise the sterile barrier.
Bovie Medical Corporation is recalling 5,270 ConMed Disposable Bipolar Ablators because pinholes in the sterile packaging may compromise the sterile barrier.
Bovie Medical Corporation is recalling 3,862 HNM Disposable Bipolar Ablators because pinholes in the sterile packaging may compromise the barrier.