Medical Device Recalls

FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Softwa

CMR SURGICAL LIMITED

McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS

Zhejiang Kindly Medical Devices Co., Ltd.

HemosIL ReadiPlasTin, Part No. 0020301400

Instrumentation Laboratory

a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7

Baxter Healthcare Corporation

Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426

Randox Laboratories Ltd.

STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray

Stradis Medical, LLC dba Stradis Healthcare

GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222;

GE Medical Systems China Co., Ltd.

Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; S

Ortho-Clinical Diagnostics, Inc.

Food Sensitivity Test Large

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2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

Fresenius Medical Care Holdings, Inc.

DeRoyal TOTAL HIP PACK, REF 89-9113.06

DeRoyal Industries Inc

Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

C.R. Bard Inc

PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8

Baxter Healthcare Corporation

VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (

Ortho-Clinical Diagnostics, Inc.

Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Micro

Kirwan Surgical Products, LLC

DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.

Philips North America Llc

GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems

GE Healthcare (China) Co., Ltd.

Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractabl

Stryker Medical Division of Stryker Corporation

Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile;

Spiggle & Theis Mt Gmbh

Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528

Medline Industries, LP

Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A

Alcon Research LLC

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001818;

Beaver Visitec International, Inc.

Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF

EITAN MEDICAL LTD

Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-151

ARROW INTERNATIONAL, LLC

Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090

ARROW INTERNATIONAL, LLC

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product

Olympus Corporation of the Americas

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump

ARROW INTERNATIONAL Inc.

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

Siemens Medical Solutions USA, Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001825;

Beaver Visitec International, Inc.