Medical Device Recalls

Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PAC

American Contract Systems Inc.

Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: Med

Integra LifeSciences Corp. (NeuroSciences)

Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

StabiliT TOUCH Syringe, REF: IN8VCF/B

Merit Medical Systems, Inc.

Single-Use Packs, REF: OPO80

Johnson & Johnson Surgical Vision, Inc.

ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL

Johnson & Johnson Vision Care, Inc.

CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures

Beaver Visitec International, Inc.

BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC

Olympus Corporation of the Americas

Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgi

Olympus Corporation of the Americas

MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3

ELEKTA SOLUTIONS AB

2008T Hemodialysis System without CDX

Fresenius Medical Care Holdings, Inc.

Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Produ

Elekta, Inc.

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Datascope Corp.

Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18

Cook Incorporated

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, mani

Medline Industries, LP

STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,

Stradis Medical, LLC dba Stradis Healthcare

NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.

Medtronic Xomed, Inc.

ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation

Olympus Corporation of the Americas

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

Beckman Coulter, Inc.

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instr

Olympus Corporation of the Americas

CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.n

St. Jude Medical

Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIR

MEDLINE INDUSTRIES, LP - Northfield

ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona

Siemens AG/Siemens Healthcare GmbH

1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN

Heartware, Inc.

LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5

Smith & Nephew Inc

Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum

Siemens Healthcare Diagnostics, Inc.

Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

Abiomed, Inc.

Impella RP with SmartAssist; Product Number: 0046-0035;

Abiomed, Inc.

Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog

Cardinal Health 200, LLC

Food Sensitivity Test Medium

GET TESTED INTERNATIONAL AB