Karl Storz Hopkins Telescope 6 endoscope recalled for unapproved reprocessing instructions
Karl Storz is recalling the Hopkins Telescope 6 endoscope because its Instructions for Use contain reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 1,982 units distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves documentation defects—specifically unapproved and unreviewed reprocessing procedures in the device's Instructions for Use. No illnesses, injuries, or adverse events are reported. Per the rubric, labeling and documentation issues with no reported harm score 2 (Moderate), and theoretical hazards with no reported incidents score at most 3.
Plain-English summary
Karl Storz Endoscopy is recalling the Hopkins Telescope 6 endoscope (Model REF: 27292AMA) due to documentation defects in its Instructions for Use. The device's reprocessing procedures—the methods for cleaning and sterilization between patients—have not been reviewed and approved by the FDA for safety and efficacy.
Proper reprocessing of endoscopes is critical to prevent cross-contamination and the transmission of infectious disease between patients. Reprocessing procedures that lack FDA review and approval cannot be verified as adequate, potentially increasing the risk of pathogen transmission and patient infection.
The recall affects 1,982 units distributed throughout the United States and U.S. territories, including all 50 states, Washington D.C., Puerto Rico, and Guam. If you currently use or have received one of these devices, contact Karl Storz Endoscopy immediately for instructions on corrective action.
Do not continue using the affected endoscope until you have received updated reprocessing instructions or replacement information from the manufacturer.
The recalled product
- Product
- Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 1,982
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)04048551233771
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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