Karl Storz Cutting Electrode Recall Due to Packaging Damage
Karl Storz is recalling 9,432 cutting electrodes due to possible sterile packaging damage that 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 describes a potential packaging defect without reporting any specific illnesses, injuries, 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, cutting, 24FR (27050G-.30/6). These are resectoscope accessories, specifically cutting electrodes, distributed nationwide in the United States and in Canada. The affected units are from Lot 36785 and Lot 36827.
The recall was initiated because of possible damage to the sterile packaging (blister tray) of the products. This damage may result in airborne contamination of the sterile medical devices.
Healthcare providers and facilities should stop using the affected lots immediately and contact Karl Storz Endoscopy America Inc for instructions on return or replacement.
The recalled product
- Product
- Electrode, cutting, 24FR (27050G-.30/6). 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 (2)
- Lot 36785
- 36827
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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