Medical Device Recalls

ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.

Mckesson Medical-Surgical Inc. Corporate Office

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems

Steris Corporation

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-1

Encore Medical, LP

i-STAT CG4+ cartridge (white). List Number: 03P85-25.

Abbott Point Of Care Inc.

LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000,

Lymol Medical Corporation

Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foi

Biomet, Inc.

Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).

Boston Scientific Corporation

Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P0

Baxter Healthcare Corporation

Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R

Aesculap Inc

B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-1

GE Healthcare Finland Oy

Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000

Siemens Medical Solutions USA, Inc

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

B Braun Medical Inc

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter

Boston Scientific Corporation

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

B Braun Medical Inc

Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-ter

Stryker Medical Division of Stryker Corporation

Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test

Baxter Healthcare Corporation

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number

MEDLINE INDUSTRIES, LP - Northfield

Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,

Medtronic Perfusion Systems

stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery

Stryker Corporation

IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.

Medical Action Industries, Inc. 306

HENRY SCHEIN, Basin Set, Item No.570-1803

Stradis Medical, LLC dba Stradis Healthcare

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Sm

Mentor Texas, LP.

Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

Biomet, Inc.

Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn T

Baxter Healthcare Corporation

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09

Merit Medical Systems, Inc.

Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

Medicina Uk Ltd

dS Breast 16ch 1.5T

Philips North America Llc

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Co

Abiomed, Inc.

BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet

CareFusion 303, Inc.

Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) inclu

Microbiologics Inc