Karl Storz Endoscopy: Medical Device Recall in 2020 - (Recall #: Z-2897-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

Product Classification:

Class II

Date Initiated: July 27, 2020

Date Posted: September 2, 2020

Recall Number: Z-2897-2020

Event ID: 86009

Reason for Recall:

Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.

Status: Ongoing

Product Quantity: 380

Code Information:

Instruction Manual Version: 01/2020

Distribution Pattern:

Worldwide distribution - U.S. Nationwide distribution including in the states of CA, NY, PA, AZ, OH, NJ, FL, NC, IL, SC, MA, IA, ND, WI, UT, AR, GA, WA, KY, CO, TX, TN, AL, LA, NE, WV, MO, MN, VA, MT, CT, MI, IN, NM, NV, ME, VT, NH, WY, DC, DE, OR, OK, MD, ID, AK, MS, KS, HI, RI, SD and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated