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.
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 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.
- Manufacturer
- Karl Storz Endoscopy America Inc
- Hazard
- 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
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