Karl Storz Hopkins Telescope 6 endoscope with unapproved reprocessing instructions
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
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 an FDA Class II recall with no reported illnesses or injuries. However, it involves a surgical endoscope where improper reprocessing due to unapproved instructions could result in serious patient harm. This meets the 'High' severity criterion as a risk-of-harm product with potential for significant adverse effects.
Plain-English summary
Karl Storz Endoscopy is recalling 425 units of the Karl Storz Hopkins Telescope 6 endoscope (Reference 27092AMA) due to safety and efficacy concerns related to reprocessing instructions. The product's Instructions for Use contain reprocessing procedures that have not been FDA-reviewed or approved.
Reprocessing procedures are critical for preparing the device for safe clinical use. The unapproved reprocessing instructions in the current IFU have not been evaluated by the FDA for their effectiveness or safety.
The recalled endoscopes were distributed nationwide across all 50 states, Washington D.C., Puerto Rico, and Guam. Affected units can be identified by UDI (01)04048551233344 and Reference 27092AMA.
Users should contact Karl Storz Endoscopy to obtain FDA-reviewed reprocessing instructions.
The recalled product
- Product
- Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 425
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)04048551233344
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.
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