Medical Device Recalls

FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software

BioFire Diagnostics, LLC

728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

Philips North America Llc

Philips V6-2 Transducer.

Philips Ultrasound, Inc

2008T Hemodialysis SYS, with CDX

Fresenius Medical Care Holdings, Inc.

EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

Olympus Corporation of the Americas

Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: S

ARROW INTERNATIONAL, LLC

Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. El

Elekta, Inc.

regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit

ROi CPS LLC

Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Descript

Dentsply IH, Inc.

Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs

Cardinal Health 200, LLC

C315-HIS Delivery Catheter

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

Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A

Waismed Ltd.

Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180

Olympus Corporation of the Americas

Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra o

Philips North America Llc

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes a

Boston Scientific Corporation

Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack N

MEDLINE INDUSTRIES, LP - Northfield

Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE

Cook Incorporated

Focalyx Fusion

Focalyx Technologies, LLC.

CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5061

Carefusion 2200 Inc

PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE

Universal Meditech Inc.

Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY

Merit Medical Systems, Inc.

Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain

The Metrix Company

DxC 700 AU, REF: B86444, B86446

Beckman Coulter Mishima K.K.

SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system

Surgical Theater Inc

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

MEDLINE INDUSTRIES, LP - Northfield

IUD Insertion Pack

Stradis Medical, LLC dba Stradis Healthcare

Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog

Cardinal Health 200, LLC

Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

Merit Medical Systems, Inc.

Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decort

Stryker Corporation