Home / Recalls / Medical Devices
Karl Storz Endoscopy recalls Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Recalled September 27, 2023 · FDA recall Z-2589-2023 · Karl Storz Endoscopy
Hazard
Flexible intubation endoscopes sterility assurance can not be confirmed. · FDA Class II
Units
218 units
Sold at
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.
Description
Flexible intubation endoscopes sterility assurance can not be confirmed.
Product
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Manufacturer(s)
Karl Storz Endoscopy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →