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Recall Observatory FDA recall evidence

Device product

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

Z-2589-2023

July 07, 2023

Class II

Product summary

Firm
Karl Storz Endoscopy
Event
Event 92796
Status
Ongoing
Classification
Class II
Quantity
218 units
Official record key
device-enforcement:Z-2589-2023

Official wording

Reason: Flexible intubation endoscopes sterility assurance can not be confirmed.

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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility assurance can not be confirmed