FDA Recalls Karl Storz Endoscopes Due to Unapproved Reprocessing Instructions
Karl Storz is recalling 78 endoscopes because their instructions for use contain reprocessing modalities that have not been reviewed or approved by the FDA.
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: This is a Class II medical device recall for an invasive endoscope with reprocessing instructions that have not been FDA-reviewed or approved. No illnesses or injuries are reported, but this represents a risk-of-harm scenario for a high-risk medical device where injury has not yet been reported, meeting the rubric threshold for High severity.
Plain-English summary
Karl Storz Endoscopy is recalling 78 units of its Hopkins Telescope 6 endoscopes (REF: 27294AA, 18 Fr) that were distributed nationwide, including all US states, DC, Puerto Rico, and Guam.
The endoscopes are being recalled because their instructions for use contain reprocessing modalities that have not been reviewed or approved by the FDA for safety and efficacy.
The recalled product
- Product
- Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- improper-reprocessing
- sterilization
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 (1)
- All Lots/UDI: (01)04048551233795
Distribution
Distributed nationwide across the United States.
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