Karl Storz Endoscopy: Device Recall

Recall #Z-3220-2024 · 07/23/2024

Class II: Risk

Recall Details

Recall Number: Z-3220-2024
Classification: Class II
Product Type: Device
Recalling Firm: Karl Storz Endoscopy
Status: Ongoing
Date Initiated: 07/23/2024
Location: El Segundo, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1982 units

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.

Product Description

Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123

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.

Other Recalls by Karl Storz Endoscopy

Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

View all recalls by Karl Storz Endoscopy →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.