Medical Device Recalls

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.

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.

Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft

Medline Industries 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.

BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispen

CareFusion 303, Inc.

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION T

MEDLINE INDUSTRIES, LP - Northfield

EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults a

Olympus Corporation of the Americas

BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solut

Young Dental Manufacturing I, LLC

Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

Trinity Sterile, Inc.

C6-2 Transducer Probe

Philips Ultrasound, Inc

Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e

MEDLINE INDUSTRIES, LP - Northfield

Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400

Aspen Surgical Products, Inc.

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Smith & Nephew, Inc.

Infa-Therm Transport Mattress, Reference Number 989805616831 1015

Philips North America Llc

Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV

GE Medical Systems, LLC