Medical Device Recalls

LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533

GE Medical Systems, LLC

GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnet

GE Healthcare, LLC

RayStation 9B SP1. For radiation treatment planning.

RAYSEARCH LABORATORIES AB

BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475

Becton Dickinson & Co.

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis

Baxter Healthcare Corporation

EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.

Staar Surgical Company

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT,

Medline Industries, LP

Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873)

Caption Health

Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Numb

Medline Industries, LP

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an

Boston Scientific Corporation

ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B

American Contract Systems Inc

Sub Q Recorder Pack, REF BPRC87A

American Contract Systems, Inc.

MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into th

Angiodynamics, Inc.

Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabiliti

ZOLL Circulation, Inc.

Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123

Karl Storz Endoscopy

Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119

Covidien, LP

stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

Wright Medical Technology, Inc.

Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080

Abbott

Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.

DIXI MEDICAL USA

MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350

Medline Industries, LP

Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)

Olympus Corporation of the Americas

Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.

DeRoyal Industries Inc

Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUN

MEDLINE INDUSTRIES, LP - Northfield

Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (

GE Healthcare, LLC

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001933;

Beaver Visitec International, Inc.

Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only

Merit Medical Systems, Inc.

Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;

DAYE (ANNE'S DAY LTD)

MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner c

MEDLINE INDUSTRIES, LP - Northfield