Karl Storz Recalls Sterile Electrodes Due to Packaging Damage
Karl Storz is recalling 9,432 sterile ball-end electrodes because damaged packaging 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 describes a potential packaging defect without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Karl Storz Endoscopy America Inc is recalling 9,432 units of Electrode, Coag, Ball End, 24FR (27050N/6) resectoscope accessories. The recall is due to possible damage to the sterile blister tray packaging, which may result in airborne contamination of the medical devices.
The affected products were distributed nationwide in the United States and in Canada. The specific lot number for this recall is 36832.
Consumers and healthcare facilities should stop using these specific electrodes and contact Karl Storz Endoscopy America Inc for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Electrode, Coag, Ball End, 24FR (27050N/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 36832
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.
See all 12 products in this recall →Related recalls
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