Karl Storz Endoscopy: Medical Device Recall in 2021 - (Recall #: Z-0184-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)

Product Classification:

Class II

Date Initiated: September 10, 2021

Date Posted: November 10, 2021

Recall Number: Z-0184-2022

Event ID: 88694

Reason for Recall:

During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.

Status: Ongoing

Product Quantity: 532

Code Information:

All LOTs with remaining shelf life

Distribution Pattern:

US: SC, NH, UT, LA, FL, TX, MA, MO, VA, IA, CA, IL, NC, VT, AL, GA, PA, TN, WI, NY, CO, AZ, NV, ME, MS, DC, IN, KY, MD, OH, MI, WA, KS, OR, AR, MN, NJ, NM, WV, CT. OUS: Canada

Voluntary or Mandated:

Voluntary: Firm initiated