Karl Storz Flexible Neuro-Fiberscope Recall Due to Incorrect Channel Port
Karl Storz Endoscopy is recalling 22 flexible neuro-fiberscopes because they were manufactured with the incorrect channel port.
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 injuries, illnesses, or specific adverse health consequences, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Karl Storz Endoscopy is recalling 22 units of the Flexible Neuro-Fiberscope, 3.7mm x 34cm, Model # 11282BN1. The recall is being initiated because the devices were manufactured with the incorrect channel port.
The affected devices were distributed to facilities in Florida, Missouri, Massachusetts, Alabama, California, Ohio, Pennsylvania, New Hampshire, Oregon, Washington, Michigan, North Carolina, and Virginia. Specific serial numbers for the recalled units are listed in the official recall documentation.
Healthcare facilities should stop using the affected devices and contact Karl Storz Endoscopy for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 22
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 (16)
- SERIAL NUMBER: 2161516
- 2204079
- 2172240
- 2198276
- 2062041
- 2178784
- 2198341
- 2220959
- 2210200
- 2183837
- 2188370
- 2247464
- 2248783
- 2194154
- 2244117
- 2039298
Distribution
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