Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Insufflation tubing to be used with varies insufflator units. REF 031200-10 Recalled by Karl Storz Endoscopy Due to The sterile single-use tubing may contain higher ethylene...

Date: January 9, 2019
Company: Karl Storz Endoscopy
Status: Terminated
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

Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10

Quantity: 543 boxes were distributed; 10 ea per box.

Why Was This Recalled?

The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.

Where Was This Sold?

This product was distributed to 27 states: AL, AZ, CA, CT, DE, FL, GA, IL, LA, ME, MD, MA, MI, MN, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VT, VA, WA, WI

Affected (27 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