device · product 1 of 8
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
- Recall number
- Z-3218-2024
- Initiated
- July 23, 2024
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Karl Storz Endoscopy
- Quantity
- 425 units
App-derived interpretation
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Official device-enrichment evidence · Sourced
Process design
Inspect official wording and provenance
Reason for recall
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)04048551233344
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.