Agency classClass IIOur severity:High FDA (Devices)·Z-3221-2024·Announced 2024-10-02

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.

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: 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
Affected units: 109

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.

The notice also names 52 states specifically:

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 →

Same manufacturer · Karl Storz Endoscopy

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Same hazard · improper sterilization