Karl Storz VaporCut Electrode Recalled for Packaging Damage
Karl Storz is recalling 9,432 VaporCut electrodes due to possible sterile packaging damage that may allow airborne contamination.
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, but the source text does not report any hospitalizations or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Karl Storz Endoscopy America Inc is recalling 9,432 units of the Electrode, VaporCut, 24FR (27050SG/6). These are resectoscope accessories, specifically electrodes, cutting loops, and cold knives, identified by Lot 36836.
The recall was initiated because of possible damage to the sterile packaging, specifically the blister tray, of these products. This damage may result in airborne contamination of the medical devices.
The affected units were distributed nationwide in the United States and in Canada. The FDA has classified this recall as Class II. Consumers and healthcare facilities should stop using the affected products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
- Manufacturer
- Karl Storz Endoscopy America Inc
- Affected units
- 9,432
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 (1)
- Lot 36836
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Karl Storz Endoscopy America Inc 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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