FDA Device Recalls

Class IICompleted

FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

Abbott Diabetes Care, Inc.

If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.

February 9, 2023 · DeviceView details →

MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device

MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device

MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device

MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device

MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device

RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001

Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415

SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030

SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030

SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415

The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.

Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122

ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon Console.

SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.

YelloPort Elite Universal Seal. For use in laparoscopic procedures.