FDA Devices Moderate Class II Ongoing

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

Reported: October 2, 2024 Initiated: July 23, 2024 #Z-3222-2024

Product Description

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

Recalling Firm: Karl Storz Endoscopy
Units Affected: 78 units
Distribution: 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.
Location: El Segundo, CA

What product was recalled? ▼

Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123. Recalled by Karl Storz Endoscopy. Units affected: 78 units.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on October 2, 2024. Severity: Moderate. Recall number: Z-3222-2024.