Medical Device Recalls

Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only

Abbott Medical

X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.

NuVasive Inc

SED URS LP, Mobile X-ray system

SEDECAL SA

A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation

Tyber Medical

VIDAS Lyme IgM II (LYM), REF 416436

bioMerieux, Inc.

InPen App, Model/CFN Number: MMT-8061 (Android Users)

Medtronic MiniMed, Inc.

stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Se

Tornier, Inc

Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes.

DEPUY (IRELAND)

Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE

Busse Hospital Disposables, Inc.

Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3)

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catal

Encore Medical, LP

See DocMan

MEDLINE INDUSTRIES, LP - Northfield

Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: S

Medline Industries, LP

LINQ II Insertable Cardiac Monitor

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E22

Defibtech, LLC

Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.

AVID Medical, Inc.

ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.

B. Braun Medical, Inc.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3D

Hologic, Inc

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH

MEDLINE INDUSTRIES, LP - Northfield

Day Surgery General Pack, FHGE18T; Medical convenience kit

American Contract Systems, Inc.

TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs

GE Healthcare Finland Oy

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

Medacta Usa Inc

MAGNETOM Prisma. Model Number: 10849582.

Siemens Medical Solutions USA, Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001836;

Beaver Visitec International, Inc.

Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No

Tecfen Medical

Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI:

Getinge Usa Sales Inc

Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.

Stryker Spine

Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog

Cardinal Health 200, LLC

ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)