Class II — Potential Health Hazard

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

Five S 5 3x65 Recalled by Karl Storz Endoscopy Due to Flexible intubation endoscopes sterility assurance can not be...

Date: July 7, 2023
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

Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

Quantity: 218 units

Why Was This Recalled?

Flexible intubation endoscopes sterility assurance can not be confirmed.

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