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Recall Observatory FDA recall evidence

Device product

Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123

Z-3221-2024

July 23, 2024

Class II

Product summary

Firm
Karl Storz Endoscopy
Event
Event 95220
Status
Ongoing
Classification
Class II
Quantity
109 UNITS
Official record key
device-enforcement:Z-3221-2024

Official wording

Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information: All Lots/UDI: (01)04048551233795

Distribution pattern: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.