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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 78
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
Part of a larger recall action
This product is one of 8 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.
See all 8 products in this recall →Related recalls
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