Medical Device Recalls

Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A

Philips North America LLC

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

Fresenius Kabi USA, LLC

8MM,PROGRASP FORCEPS,IS4000 REF 471093

Intuitive Surgical, Inc.

Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)

Freudenberg Medical, Llc

Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116).

TELEFLEX LLC

BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recogn

Becton, Dickinson and Company, BD Biosciences

Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.

ROi CPS LLC

Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended

Wilson-Cook Medical Inc.

Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-591

Mckesson Medical-Surgical Inc. Corporate Office

3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape

3M Healthcare Business

MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007

SEDECAL SA

Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic

Mindray DS USA, Inc. dba Mindray North America

ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therap

Siemens Medical Solutions USA, Inc

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-263

Sklar Instruments

FoundationOne CDx (F1CDx), RAL-0003 version 31.0

Foundation Medicine, Inc.

Pediatric Craniotome Ref:CRANI-P-G1

The Anspach Effort, Inc.

Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool

Argon Medical Devices, Inc

Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a

Windstone Medical Packaging, Inc.

Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW

Tenderneeds Fertility LLC

Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010

ICU Medical Inc

OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging sy

GE OEC Medical Systems, Inc

ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

Beckman Coulter Mishima K.K.

ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401

Biomerieux Inc

Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)

D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-

Maquet Medical Systems USA

Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL

Baxter Healthcare Corporation

ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553

Biomerieux Inc

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

Merit Medical Systems, Inc.

Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, St

Edwards Lifesciences, LLC