Medical Device Recalls

Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System

GE Healthcare

Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC2

Merit Medical Systems, Inc.

Biograph mMR. Model Number: 10433372.

Siemens Medical Solutions USA, Inc

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FI

MEDLINE INDUSTRIES, LP - Northfield

Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G

MEDLINE INDUSTRIES, LP - Northfield

Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammogra

GE Healthcare, LLC

Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12

ICU Medical, Inc.

Candida Test

GET TESTED INTERNATIONAL AB

SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

B Braun Medical Inc

UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG

American Contract Systems Inc

3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370

3M Company

Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);

Philips North America

SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110

Howmedica Osteonics Corp.

ASG-001; Ultrasound gel

Advance Medical Designs, Inc.

UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-b

Medicrea International

MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

Micro-X Ltd.

Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Versi

Oxos Medical Inc

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition s

GE Healthcare, LLC

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. F

Cook Incorporated

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

Medline Industries, LP

Intera 1.5T Omni/Stellar, Magnetic Resonance System.

Philips North America Llc

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump

ARROW INTERNATIONAL Inc.

KIT,SPINE LH Convenience kit, SKU DYNJ906448A.

MEDLINE INDUSTRIES, LP - Northfield

8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401

Intuitive Surgical, Inc.

OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy

GE Medical Systems, LLC

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E

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

Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery

Baxter Healthcare Corporation

Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Ve

MEDLINE INDUSTRIES, LP - Northfield

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.