Medical endoscope recalled for unapproved sterilization instructions
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing methods that lack FDA review and approval.
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 recall for a medical device with unapproved reprocessing instructions used in invasive procedures. While no illnesses or injuries have been reported, improper sterilization poses a clear risk of serious infection and meets the criteria for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Karl Storz Endoscopy is recalling 109 units of Karl Storz Hopkins Telescope 6 endoscopes (REF: 27293AA) distributed nationwide across the United States and its territories, including Puerto Rico and Guam.
The recall is issued because the Instructions for Use (IFU) provided with the device contain reprocessing modalities—methods for sterilization and preparation for reuse—that have not been reviewed or approved for safety and efficacy by the FDA.
Affected units can be identified by the reference number 27293AA and the UDI code (01)04048551233795. This is classified as a Class II recall.
The recalled product
- Product
- Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscopy
- Hazard
- improper-sterilization
- contamination
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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