FDAFDA · Food and drugs·Recall number Z-3223-2024
Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Published October 2, 2024 · Recall initiated: July 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Karl Storz Endoscopy
- Distributor
- 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.
- Lot
- All Lots/UDI: (01)04048551233856
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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