Medical Device Recalls

Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable steril

Guangdong Haiou Medical Apparatus Co., Ltd

Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F

SunMed Holdings, LLC

10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Fresenius Medical Care Holdings, Inc.

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055

TELEFLEX LLC

REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01

Limacorporate S.p.A

Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device

Baxter Healthcare Corporation

NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented

Novosource, LLC

SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use

GE Medical Systems, LLC

Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory

Draeger Medical Systems, Inc.

regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit

ROi CPS LLC

DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145

Cardiovascular Systems Inc

RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d

Teleflex Medical Europe Ltd

Permobil TiLite, Models: Aero Z, and ZRA

TiSport, Llc

Unity Total Knee System. Used for knee prosthesis in total knee replacement

Corin Ltd

Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691

MEDLINE INDUSTRIES, LP - Northfield

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002080;

Beaver Visitec International, Inc.

CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with Syner

Artivion, Inc

TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z

Acclarent, Inc.

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25

Abiomed, Inc.

Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case

MEDLINE INDUSTRIES, LP - Northfield

CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to conta

The Metrix Company

Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen

Cardinal Health 200, LLC

Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658

Siemens Medical Solutions USA, Inc

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an inter

Boston Scientific Corporation

18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;

DAYE (ANNE'S DAY LTD)

STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431

Stradis Medical, LLC dba Stradis Healthcare

Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T,

ARROW INTERNATIONAL, LLC

DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108

Encore Medical, LP

Medical convenience kits UDPG88W PICC G-TUBE PACK-230209

American Contract Systems Inc.

PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035

Biomerieux Inc