Medical Device Recalls

Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, H

Hamilton Medical AG

Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179,

Henry Schein Inc.

Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215

Corin Ltd

MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;

Philips North America

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001376;

Beaver Visitec International, Inc.

The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the d

Stryker Neurovascular

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000305;

Beaver Visitec International, Inc.

Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010

Stryker Corporation

ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated

Zimmer, Inc.

UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

Neotract Inc

Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PA

MEDLINE INDUSTRIES, LP - Northfield

Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF

SEDECAL SA

Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number

Abbott Laboratories

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fr

Waldemar Link GmbH & Co. KG (Mfg Site)

Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K13329

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080

Abiomed, Inc.

Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 6050001010

Zimmer Surgical Inc

API NIT1 NIT2 REAGENTS, CATALOG 70442

Biomerieux Inc

Basic Biopsy Tray, Item Number NMBP44L

American Contract Systems Inc.

Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

OSSTEM Implant Co., Ltd.

Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.

LEICA BIOSYSTEMS NUSSLOCH GMBH

CYSTO PACK , Model N. HKCY31A

American Contract Systems Inc

BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-K

Orthorebirth Co Ltd

PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardi

Ethicon, Inc.

IV Non-Dedicated Gravity Administration Sets with drip chambers

ICU Medical, Inc.

Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.

Philips North America

CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3S

Carefusion 2200 Inc

HENRY SCHEIN, RHINO PACK, Item No.570-3070

Stradis Medical, LLC dba Stradis Healthcare

EasyPoint Needle, 25G x 5/8", REF: 82091

Retractable Technologies, Inc.