FDA recall Z-1474-2024

Karl Storz Endoscopy · Class II · device

Product

Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only

Reason for recall

Inadequate reprocessing validation evidence

Distribution

US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.

Key facts

Status
Ongoing
Initiation date
2024-02-27
Report date
2024-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Segundo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1474-2024