Karl Storz Cutting Loops Recalled for Packaging Damage
Karl Storz is recalling 9,432 cutting loops 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 illnesses, injuries, or hospitalizations. The hazard is a potential contamination risk due to packaging damage, which aligns with the criteria for a moderate severity score involving low-risk contamination or precautionary measures without reported harm.
Plain-English summary
Karl Storz Endoscopy America Inc is recalling 9,432 units of Loop, Cutting, 24FR (26050G/6) resectoscope accessories. The recall is due to possible damage to the sterile packaging (blister tray) of the products, which may result in airborne contamination.
The affected products were distributed nationwide in the United States and in Canada. The specific lot number is 36781.
Consumers and healthcare facilities should stop using these products and contact Karl Storz Endoscopy America Inc for instructions on return or replacement.
The recalled product
- Product
- Loop, Cutting, 24FR (26050G/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 36781
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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