Medical Device Recalls

Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.

Brainlab AG

FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Philips X3-1 Ultrasound Transducer

Philips Ultrasound, Inc

Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw

Acumed LLC

Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single

Bard Peripheral Vascular Inc

The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (S

Intuitive Surgical, Inc.

Colonoscope, Model Number CF-HQ190L.

Olympus Corporation of the Americas

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PA

MEDLINE INDUSTRIES, LP - Northfield

ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar

B Braun Medical Inc

Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS,

SEASPINE ORTHOPEDICS CORPORATION

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001176;

Beaver Visitec International, Inc.

DeRoyal LUMBAR DISC PACK, REF 89-10590.02

DeRoyal Industries Inc

ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.

Abbott Laboratories

therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

Qiagen Sciences LLC

Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A

MEDLINE INDUSTRIES, LP - Northfield

Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip art

Howmedica Osteonics Corp.

iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

Beta Bionics, Inc.

Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti

Philips North America

DxM 1040 MicroScan WalkAway Instrument REF B1018-440

Beckman Coulter Inc.

Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29

AVID Medical, Inc.

FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monito

Abbott Diabetes Care, Inc.

MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. elec

MEDLINE INDUSTRIES, LP - Northfield

Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187

Cardinal Health 200, LLC

Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;

Medline Industries, LP

Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case

MEDLINE INDUSTRIES, LP - Northfield

STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop a

Diagnostica Stago, Inc.

ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE

Medline Industries, LP