Medical Device Recalls

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance

GE Healthcare, LLC

Material Processing Laser Products

SHENZHEN ATOMSTACK TECHNOLOGIES

FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

Inpeco S.A.

AggreGuide A-100 Instrument

Aggredyne, Inc.

HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900

Howmedica Osteonics Corp.

Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE

MEDLINE INDUSTRIES, LP - Northfield

DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.

SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910

Synthes (USA) Products LLC

DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A

Merit Medical Systems, Inc.

T-SPOT.TB REF TB.300 US

OXFORD IMMUNOTEC LTD

stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation

Wright Medical Technology, Inc.

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors M

Zimmer Surgical Inc

PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator

Medtronic Inc.

Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radi

Surgical Theater Inc

Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Conn

Silex Medical, LLC

PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and

B BRAUN MEDICAL INC

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM

Exactech, Inc.

Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555

TELEFLEX LLC

Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16

AVID Medical, Inc.

Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.

Stradis Healthcare

REGARD Stereotactic Tray

ROi CPS LLC

ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Ma

Siemens Medical Solutions USA, Inc

regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit

ROi CPS LLC

The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross

Philips North America Llc

Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile s

Jiangsu Shenli Medical Production Co., Ltd.

20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box

CellEra LLC

These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, viruc

MEDLINE INDUSTRIES, LP - Northfield

EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380

Philips North America Llc

QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalact

Microbiologics Inc

Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleare

Boston Scientific Corporation