Recall Z-1010-2026— Applied Medical Resources Corp

Name: FDA recall Z-1010-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-11

Class II · Ongoing

Class II FDA medical device recall by Applied Medical Resources Corp, initiated 2025-12-11. It names one FDA 510(k) clearance: K060096. Product: Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23. Reason: There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing..

Recalling firm: Applied Medical Resources Corp
Classification: Class II
Status: Ongoing
Initiated: 2025-12-11
Firm location: Rancho Santa Margarita, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K060096 — MODULAR TROCAR SYSTEMApplied Medical Resources Corp.·cleared 2006-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.