The Recall Desk
ModerateFDA (Devices)·Z-1315-2013·Announced 2013-05-22

Karl Storz Cutting Electrodes Recalled for Packaging Damage

Karl Storz is recalling 9,432 cutting electrodes due to possible damage to sterile packaging 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. The hazard involves potential contamination due to packaging damage, but the source text does not report any 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, 0.30MM (27040G-.30/6). These are resectoscope accessories, specifically cutting electrodes, distributed nationwide and in Canada.

The recall is being issued because of possible damage to the sterile packaging (blister tray) of the products. This damage may result in airborne contamination of the medical devices.

Healthcare providers and facilities should stop using the affected units and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
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 36897

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 →

Same manufacturer · Karl Storz Endoscopy America Inc

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