Medical Device Recalls

TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.

TEI Biosciences, Inc.

OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.

Integra LifeSciences Corp. (NeuroSciences)

Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table

Oakworks Inc

Am I Pregnant? One Step HCG Pregnancy Test REF 100-17

Universal Meditech Inc.

Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Num

Baxter Healthcare Corporation

Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/P

Windstone Medical Packaging, Inc.

Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)

Medline Industries, LP

Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094

DATEX--OHMEDA, INC.

Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2.

Insulet Corporation

Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X

Philips Respironics, Inc.

Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusi

Covidien Llc

HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STER

Stryker Sustainability Solutions

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 834338

QUIDEL ORTHO

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001478;

Beaver Visitec International, Inc.

Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 In

Merit Medical Systems, Inc.

LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400

MICROVENTION INC.

Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436

Medline Industries, LP

Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03;

Exactech, Inc.

Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interve

Siemens Medical Solutions USA, Inc

ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile- Indicat

Zimmer, Inc.

OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D

OrganOx Ltd

Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is

Philips Medical Systems Technologies Ltd.

Ingenia 1.5T S Model Number (REF): 781347

Philips North America Llc

TECNIS Toric II OptiBlue IOL Models ZCW

Johnson & Johnson Surgical Vision, Inc.

Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A

Philips North America LLC

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000803;

Beaver Visitec International, Inc.

MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632

MEDLINE INDUSTRIES, LP - Northfield

TruSignal Ear Sensor, REF TS-E-D; Oximeter

GE Healthcare Finland Oy

MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector

MEDLINE INDUSTRIES, LP - Northfield

Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610

Mckesson Medical-Surgical Inc. Corporate Office