KARL STORZ Nasopharyngolaryngoscope Disinfection Failure Affects 14 States
The FDA is recalling KARL STORZ Slim Nasopharyngolaryngoscope models 11001RD1 and 11001RDK1 because they fail to achieve adequate disinfection, potentially allowing microorganisms to persist on the device and transmit between patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with documented disinfection process failure affecting an invasive procedure with infection transmission risk. No illnesses or injuries have been reported, meeting the threshold for high-risk products without yet-realized harm.
Plain-English summary
Karl Storz Endoscopy is recalling KARL STORZ Slim Nasopharyngolaryngoscope models 11001RD1 and 11001RDK1 (Version 5.0, manufactured or distributed since January 2018). The devices fail to achieve the expected six-log reduction in microorganisms following the standard disinfection process.
Nasopharyngolaryngoscopes are rigid endoscopes used to visualize the throat and nasal passages during medical examinations and procedures. Proper disinfection between patient uses is critical to prevent microorganism transmission. When disinfection is incomplete, residual microorganisms on the device surface can transmit infectious agents to subsequent patients.
The affected devices are distributed nationwide in Florida, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, New Hampshire, New Jersey, Oklahoma, South Carolina, Texas, and Washington.
Healthcare facilities and consumers who have these devices should cease use and contact Karl Storz Endoscopy for instructions regarding replacement or repair of affected units.
The recalled product
- Product
- 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscope
- Affected units
- 2,018
Distribution
Part of a larger recall action
This product is one of 2 recalled by Karl Storz Endoscopy 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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