FDA-Device2026-01-14Class IIPROCESSING DEFECT
Applied Medical Resources Kii Low Profile trocar recalled for blade assembly defect
Stop using Applied Medical Kii Low Profile trocars
Applied Medical Resources has recalled certain Kii Low Profile trocar units because the blade obturator may extend beyond its proper length after assembly. This defect could affect the device's safe function during use. No injuries have been reported.
- Stop using Kii Low Profile Bladed Dual Pack trocars (REF: CTB23, Lot #1546141)
- Contact Applied Medical Resources or your supplier for instructions on return or replacement
- Check your facility inventory for affected lot numbers and secure them
Hazard
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Sold states
US: MI, CA, ME, OUS: France Great Britain, Germany
Affected count
450 units
Manufactured in
22872 Avenida Empresa, Rancho Santa Margarita, CA, United States
Products
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1010-2026Don't want to check this manually?
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