Medical Device Recalls

HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak

Physio-Control, Inc.

GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.

GE Medical Systems China Co., Ltd.

FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-67

Insulet Corporation

ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor

Medtronic Inc.

LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Ver

Boston Scientific Corporation

Cepheid, Sample Collection Device, Part: 900-0370

Cepheid

GEM Premier 5000; Model No. 00055430010.

Instrumentation Laboratory

RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.

RAYSEARCH LABORATORIES AB

Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07

AVID Medical, Inc.

Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD5

Getinge Usa Sales Inc

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis

Baxter Healthcare Corporation

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

B Braun Medical Inc

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLB

American Contract Systems Inc

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

GE Healthcare, LLC

Regard Dressing change kit, Item Number 800026006

ROi CPS LLC

EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator

Boston Scientific Corporation

The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manu

QUANTUM SURGICAL SAS

ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-0

Boston Scientific Corporation

Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty

Exactech, Inc.

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY

AVID Medical, Inc.

BF-MP160F: EVIS EXERA Bronchofibervideoscope

Olympus Corporation of the Americas

Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.

XTANT Medical Holdings, Inc

Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001

Outset Medical, Inc.

Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K1306

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395

MEDLINE INDUSTRIES, LP - Northfield

mC7-2 Transducer Probe

Philips Ultrasound, Inc

Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-q

Becton Dickinson & Co.

Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M Product Description: NON-Sterile s

Jiangsu Shenli Medical Production Co., Ltd.

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.

Caire, Inc.