Karl Storz Cutting Electrode Recall Due to Packaging Damage
Karl Storz is recalling cutting electrodes because damaged sterile packaging may allow airborne contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 illnesses, injuries, or hospitalizations, and the hazard is a potential contamination risk rather than a confirmed adverse event.
Plain-English summary
Karl Storz Endoscopy America Inc is recalling 9,432 units of cutting electrodes (model 27050G/6) and related resectoscope accessories. The recall is due to possible damage to the sterile blister tray packaging, which may result in airborne contamination of the devices.
The affected products were distributed nationwide in the United States and in Canada. The specific lots involved are 36775, 36786, 36828, and 36864.
Healthcare providers and facilities should stop using these devices and contact Karl Storz Endoscopy America Inc for instructions on return or replacement.
The recalled product
- Product
- Electrode, cutting, 24FR (27050G/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 (4)
- Lot 36775
- 36786
- 36828
- 36864
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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