Medical Device Recalls

Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722

Getinge Usa Sales Inc

EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an

DePuy Spine, Inc.

Medline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485L

Medline Industries, LP

Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00

Elekta, Inc.

BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿

Becton Dickinson & Co.

Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123

Karl Storz Endoscopy

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

CELLTRION USA INC

KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K

Microbiologics Inc

Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-1

Cook Medical Incorporated

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

Smiths Medical ASD, Inc.

VITROS XT 7600 Integrated System, Catalog No. 6844461

Ortho-Clinical Diagnostics, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001054;

Beaver Visitec International, Inc.

DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23

Katalyst Surgical, LLC

Penner Pacific Bathing Spa, Model Numbers 860010-1L

Penner Patient Care, Inc.

Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Vers

Turncare, Inc

smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71

Smith & Nephew Inc

Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00

CareFusion 303, Inc.

CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators

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

Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

General Manual surgical instrument

M.D.L. S.r.l.

Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag P

Cardinal Health

SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030

Chamberlain Technologies LLC

MiniMed 780G Insulin Pump (O.U.S. Version)

Medtronic MiniMed

Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D

Medtronic Neuromodulation

RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.

RAYSEARCH LABORATORIES AB

3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16

GE Medical Systems, LLC

Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLI

Boston Scientific Corporation

EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.

Covidien, LP

Kit: Central Line Dres Change 20/Cs

Medical Action Industries, Inc. 306

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL

Covidien, LP