FDA DeviceClass IINotable
FDA Recall: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Description
A product error defect may cause incorrect bracket placement.
Hazard
A product error defect may cause incorrect bracket placement.
Remedy
3 units
Related Recalls
2026-07-22 · FDA_DEVICE
FDA Recall: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma exter
Orthofix U.S. LLC
2026-07-22 · FDA_DEVICE
FDA Recall: ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
ICU Medical, Inc.
2026-07-22 · FDA_DEVICE
FDA Recall: One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Argon Medical Devices, Inc
2026-07-22 · FDA_DEVICE
FDA Recall: Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Medline Industries, LP