Karl Storz Recalls Flexible Intubation Fiberscopes Due to Material Issue
Karl Storz Endoscopy America is recalling specific flexible intubation fiberscopes because the suction channel material is incompatible with STERRAD sterilization systems.
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 hazard involves a material compatibility issue with sterilization systems rather than a direct, reported injury or high-risk pathogen, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Karl Storz Endoscopy America, Inc. is recalling the Intubation Flexible Fiberscope, including models 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2. The recall involves 1,516 units that were distributed nationwide.
The recall was initiated because the material used in the suction channel portion of the devices was thermoplastic polyurethane (TPU). This material is not listed in STERRAD systems claims for interior endoscope lumens, meaning the devices may not be compatible with this specific sterilization method.
Healthcare facilities and users should identify affected units by checking the model numbers and codes C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, and QKC1694E. Users should contact Karl Storz Endoscopy America for instructions on how to proceed with the recall.
The recalled product
- Product
- Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2. " Transoral intubation " Transnasal intubation " Evaluation of placement of endotracheal and double lumen endotracheal tubes " Provide…
- Manufacturer
- Karl Storz Endoscopy America Inc
- Category
- Medical Device — Endoscopy
- Affected units
- 1,516
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 (8)
- C1140
- C1140E
- C1160
- C1160E
- QKC1750
- QKC1750E
- QKC1694
- QKC1694E
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
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