Medical Device Recalls

Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system c

Philips North America Llc

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723

MEDLINE INDUSTRIES, LP - Northfield

DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06

DeRoyal Industries Inc

Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model Number: 221265

Mckesson Medical-Surgical Inc. Corporate Office

Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

SCIENCE & BIO MATERIALS

20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.

Abbott Vascular Inc

Achieva 1.5T

Philips North America Llc

SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051

DiaSorin Molecular LLC

L12-3 Transducer Probe

Philips Ultrasound, Inc

Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The

Angel Medical Systems, Inc.

Intera 1.5T Omni/Stellar, Model Number: 781104;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Philips Respironics, Inc.

Diowave Laser System, REF: Diowave 250W

Technological Medical Advancements LLC

BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859

Maquet Medical Systems USA

GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A131

Medicrea International

Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

ROi CPS LLC

Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)

Cook Incorporated

Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, OVERALL LENGTH 7-1/2" (190MM), REF F-1111

Carefusion 2200 Inc

medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 0

Smiths Medical ASD Inc.

Parasite Test

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CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators

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

CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators

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

RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfar

Emergent Protective Products USA Inc

Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C1

Beckman Coulter, Inc.

11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-

Karl Storz Endoscopy

NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700

Smiths Medical ASD Inc.

DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system

Philips Medical Systems DMC GmbH

Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass

B. Braun Medical, Inc.