Medical Device Recalls

Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DY

Medline Industries, LP

RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

Ossur H / F

Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

Cepheid

Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

Olympus Corporation of the Americas

STERILE PVP SOLUTION, REF DYNDA1907

MEDLINE INDUSTRIES, LP - Northfield

Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16

Galt Medical Corporation

Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10

Pentax of America Inc

PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF

Entopsis , Inc.

Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial f

Medtronic, Inc.

ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model num

PROTERIXBIO

REGARD Vitrectomy Tray

ROi CPS LLC

GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system

GE Healthcare (China) Co., Ltd.

15 Liters Drain Bag

Baxter Healthcare Corporation

Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model

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

GE Vscan Extend, being sold as "Vscan Extend Dual USB"

GE Healthcare, LLC

Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator

Medtronic Inc.

DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15

DeRoyal Industries Inc

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

Zimmer, Inc.

Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-3

Cook Incorporated

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001602;

Beaver Visitec International, Inc.

Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software

Alcon Research LLC

Puritan Bennett 980 Series Ventilator, 980U1ENASAA

Covidien Llc

Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiati

Philips North America Llc

REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL

Abbott Laboratories

TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.

Howmedica Osteonics Corp.

Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S

Riverpoint Medical, LLC

Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software V

B Braun Medical Inc

Pneupac paraPac plus 300 ventilator kit, REF P300NGB

Smiths Medical ASD Inc.

medex Arterial Kit 1/EA, Product Code REF MX7827

Smiths Medical ASD, Inc.

ASM Replacement Battery, Component Number SUB0000864

ICU Medical Inc