Karl Storz Recalls Cold Straight Knives Due to Packaging Damage
Karl Storz is recalling 9,432 units of cold straight knives because damaged sterile 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: This is a Class II recall involving a potential contamination risk without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Karl Storz Endoscopy America Inc is recalling 9,432 units of Knife, Cold, Straight (27068K/6) resectoscope accessories. The recall is due to possible damage to the sterile packaging, specifically the blister tray, which may result in airborne contamination of the sterile products.
The affected products were distributed nationwide in the United States and in Canada. The specific lot number is 36851.
Consumers and healthcare facilities should stop using these products and contact Karl Storz Endoscopy America Inc for instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- Knife, Cold, Straight (27068K/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 36851
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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