FDA recall Z-1472-2024

Karl Storz Endoscopy · Class II · device

Product

Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, 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-1472-2024