Karl Storz Recalls Flexible Broncho Fiberscopes Due to Material Issue
Karl Storz Endoscopy America is recalling 141 flexible broncho fiberscopes because the suction channel material is not listed for STERRAD sterilization systems.
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 does not report any hospitalizations, injuries, or illnesses. The hazard is a material compatibility issue with sterilization systems, which fits the criteria for a moderate severity recall involving potential but unreported risks.
Plain-English summary
Karl Storz Endoscopy America, Inc. is recalling 141 units of the Broncho Flexible Fiberscope and Flexible Intubation Fiberscope. The affected models are 11001BN1, 11002BD1, 11004BC1, and 11009BC1. These devices were distributed nationwide.
The recall was initiated because the material used in the suction channel portion of the devices is thermoplastic polyurethane (TPU). This specific material is not listed in STERRAD systems claims for interior endoscope lumens. The agency has classified this as a Class II recall.
Healthcare facilities should stop using the affected devices and contact the manufacturer for instructions on return or replacement. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias " Unc
- Manufacturer
- Karl Storz Endoscopy America Inc
- Category
- Medical Device — Endoscopy
- Affected units
- 141
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.
See all 2 products in this recall →Related recalls
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