Medical Device Recalls

GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02

Sonendo Inc

Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices w

Globus Medical, Inc.

Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model number

MEDLINE INDUSTRIES, LP - SPT

Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource

Cardinal Health 200, LLC

PhenoMATRIX

Copan WASP

CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

CoreLink LLC

BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 an

Becton Dickinson & Co.

DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

Philips North America Llc

TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractur

Synthes (USA) Products LLC

Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in v

Diagnostica Stago, Inc.

KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco re

Kinova Inc

Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C

MEDLINE INDUSTRIES, LP - Northfield

microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as

Landauer

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline K

Medline Industries, LP

Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

Beckman Coulter, Inc.

Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Mo

Medtronic Neuromodulation

PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416

Howmedica Osteonics Corp.

Medicine Dropper, Product Code K508

Apothecary Products, LLC

Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;

Philips North America

DeRoyal LUMBAR FUSION PACK, REF 89-10211.05

DeRoyal Industries Inc

namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit

MEDLINE INDUSTRIES, LP - Northfield

CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators

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

Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Ant

Cardinal Health 200, LLC

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade

Biomet, Inc.

Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 31

Roche Diagnostics Operations, Inc.

STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,

Stradis Medical, LLC dba Stradis Healthcare

Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

LEICA BIOSYSTEMS NUSSLOCH GMBH

Identity Imprint PS Tibial Tray Size 4: Lot 540287

Conformis, Inc.

Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

Zoe Medical Incorporated

Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261

Merit Medical Systems, Inc.