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Karl Storz Endoscopy recalls FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Recalled November 10, 2021 · FDA recall Z-0184-2022 · Karl Storz Endoscopy
Hazard
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. · FDA Class II
Units
532
Sold at
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
Description
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.
Product
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Manufacturer(s)
Karl Storz Endoscopy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →