Karl Storz Flexible Intubation Fiberscopes Recalled for Manufacturing Defect
Karl Storz Endoscopy is recalling 14 Flexible Intubation Fiberscopes because they were improperly manufactured with a double port luer instead of a single port luer.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Karl Storz Endoscopy is recalling 14 units of the Flexible Intubation Fiberscope, Model # 11301AB1. The recall was initiated because the intubation scopes were improperly manufactured with a double port luer instead of the required single port luer.
The affected devices were distributed in the United States to Virginia, Missouri, California, Ohio, New Mexico, New York, Colorado, Louisiana, and Maine, as well as in Canada. The specific lot numbers involved in this recall are 2183827, 2195794, 2215741, 2229258, 2235373, 2248169, and 2193769.
Healthcare facilities and users should stop using the affected devices and contact Karl Storz Endoscopy for further instructions regarding the recall.
The recalled product
- Product
- Flexible Intubation Fiberscope, Model # 11301AB1
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 14
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 (7)
- Lot numbers: 2183827
- 2195794
- 2215741
- 2229258
- 2235373
- 2248169
- 2193769
Distribution
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