Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) Recalled by Karl Storz Endoscopy Due to Failure to achieve the expected six-log reduction in...

Date: April 1, 2022
Company: Karl Storz Endoscopy
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Karl Storz Endoscopy directly.

Affected Products

11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)

Quantity: All Serial Numbers manufactured/distributed since January 2018.

Why Was This Recalled?

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Karl Storz Endoscopy

Karl Storz Endoscopy has 70 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report