Karl Storz Hopkins Telescope Recalled for Unapproved Reprocessing Instructions
Karl Storz Hopkins Telescope 6 endoscopes are being recalled because the instructions for use contain reprocessing procedures not reviewed or approved by the FDA. Affected units should not be used until corrected instructions are provided.
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 recall involving instructions for use that contain unapproved reprocessing procedures. While no illnesses or injuries have been reported, improper reprocessing could compromise device safety and efficacy. This constitutes a risk-of-harm product where injury has not yet been reported, meeting the Score 3 criterion.
Plain-English summary
Karl Storz Endoscopy is recalling the Hopkins Telescope 6 endoscope (REF 27093AA, Class II) because the instructions for use contain reprocessing procedures that have not been reviewed or approved by the FDA for safety and efficacy.
Thirty-four units of the device were distributed nationwide across all U.S. states and territories. The defect involves the procedures described in the device's instructions for reprocessing prior to reuse.
Healthcare facilities and patients should immediately contact Karl Storz Endoscopy for corrected instructions. Do not use the device with the current reprocessing procedures until updated, FDA-reviewed instructions are received. The manufacturer is providing replacement instructions to address this deficiency.
The recalled product
- Product
- Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- unapproved-reprocessing
- instruction-defect
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)04048551233368
Distribution
Distributed nationwide across the United States.
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