Karl Storz Hopkins Telescope 6 Endoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz Hopkins Telescope 6 endoscopes (59 units, nationwide) are recalled because their reprocessing instructions lack FDA review and approval for safety and efficacy.
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 FDA Class II recall involves reprocessing procedures that lack FDA review and approval, representing a risk-of-harm product where improper sterilization could compromise patient safety. No illnesses or injuries have been reported, which limits the score to High per rubric criteria for risk-of-harm products without documented injury.
Plain-English summary
Karl Storz Endoscopy is recalling the Karl Storz Hopkins Telescope 6 endoscope (REF: 27295AA, 18 Fr) distributed nationwide. A total of 59 units are affected across all 50 U.S. states, Washington DC, Puerto Rico, and Guam (UDI: (01)04048551233856, all lot numbers included).
The recalled endoscopes' instructions for use contain reprocessing modalities that have not been reviewed or approved by the FDA for safety and efficacy. This creates a risk that users following these instructions may not adequately reprocess the device to FDA standards.
Healthcare providers and facilities that have received this device should immediately cease using the affected endoscopes. Contact Karl Storz Endoscopy for device replacement or return instructions.
The recalled product
- Product
- Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscope
- Hazard
- improper-reprocessing
- sterilization-hazard
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)04048551233856
Distribution
Distributed nationwide across the United States.
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