Karl Storz Endoscopy recalls Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123

Recall date: July 23, 2024
Source: U.S. Food & Drug Administration (FDA) — enforcement report
Recall number: Z-3222-2024
FDA classification: Class II
Brand / firm: Karl Storz Endoscopy
Sold / distributed: 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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123

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