Karl Storz Endoscopy: Medical Device Recall in 2023 - (Recall #: Z-2589-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 7, 2023

Date Posted: September 27, 2023

Recall Number: Z-2589-2023

Event ID: 92796

Reason for Recall:

Flexible intubation endoscopes sterility assurance can not be confirmed.

Status: Ongoing

Product Quantity: 218 units

Code Information:

UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated