Karl Storz Recalls Pointed Coagulation Electrodes Due to Packaging Damage
Karl Storz is recalling 9,432 units of pointed coagulation electrodes because damage to the sterile blister tray 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. 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 voluntary precautionary measures without reported harm.
Plain-English summary
Karl Storz Endoscopy America Inc is recalling 9,432 units of Electrode, Coag, Pointed, 24FR (27050L/6). These products are resectoscope accessories, specifically electrodes, cutting loops, and cold knives. The recall is limited to Lot 36829.
The recall was initiated because of possible damage to the sterile packaging, specifically the blister tray, of some Karl Storz sterile 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. Consumers and healthcare facilities should stop using these specific units and contact Karl Storz Endoscopy America Inc for instructions on return or replacement.
The recalled product
- Product
- Electrode, Coag, Pointed, 24FR (27050L/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 36829
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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