The Recall Desk
ModerateFDA (Devices)·Z-0465-2014·Announced 2013-12-18

Karl Storz Recalls Misidentified Axillent Debakey Grasping Forceps

Karl Storz is recalling 7 units of Axillent Debakey Grasping Forceps because they were mislabeled as a different model.

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 describes a labeling error without reporting any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

Karl Storz Endoscopy America Inc is recalling 7 units of Axillent Debakey Grasping Forceps, Part No. 33821DYD. The recall was initiated because the 33821WTD Wavy grasper was mislabeled as the 33821DYD Axillent Debakey Grasping Forceps.

The affected products were distributed nationwide, including in Texas, Pennsylvania, and New York. The specific lot code for the recalled items is YX.

Consumers and healthcare facilities should stop using the affected forceps and contact Karl Storz Endoscopy America Inc for further instructions.

The recalled product

Product
Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
Affected units
7

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 Code YX

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Same manufacturer · Karl Storz Endoscopy America Inc

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