Medical Device Recalls

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

Baxter Healthcare Corporation

DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Ex

ConvaTec, Inc

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.

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation

Exactech, 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.

Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device

C.R. Bard Inc

BioZorb Marker. Radiographic soft tissue marker.

Hologic, Inc

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 0002434500

Instrumentation Laboratory

Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.

DEPUY (IRELAND)

Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US So

Thoratec LLC

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722

Hobbs Medical, Inc.

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050

TELEFLEX LLC

GE Signa Voyager, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosur

Stryker Corporation