FDA recall Z-1010-2026

Applied Medical Resources Corp · Class II · device

Product

Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23

Reason for recall

There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.

Distribution

US: MI, CA, ME, OUS: France Great Britain, Germany

Key facts

Status
Ongoing
Initiation date
2025-12-11
Report date
2026-01-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rancho Santa Margarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1010-2026