Medical Device Recalls

Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;

Abiomed, Inc.

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12

Waldemar Link GmbH & Co. KG (Mfg Site)

IntelliVue Patient Monitor MX400. Product Number: 866060.

Philips North America Llc

SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT

Bard Peripheral Vascular Inc

a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Numb

Mckesson Medical-Surgical Inc. Corporate Office

MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J

MEDLINE INDUSTRIES, LP - Northfield

Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number D

MEDLINE INDUSTRIES, LP - Northfield

1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack

American Contract Systems, Inc.

Spectrum IQ Infusion pump, Product Code 357009

Baxter Healthcare Corporation

Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pa

Zyno Medical LLC

Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5

Olympus Corporation of the Americas

SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of maligna

Cordis Corporation

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

MEDLINE INDUSTRIES, LP - Northfield

stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in str

Tornier S.A.S.

1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30

GE Medical Systems, LLC

Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Num

Cardinal Health 200, LLC

DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system

Philips Medical Systems DMC GmbH

Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual a

Rebiscan, Inc.

HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterog

CooperSurgical, Inc.

ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabi

Zimmer, Inc.

. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP

Nobel Biocare

Centricity PACS RA1000

GE Healthcare, LLC

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance

Ortho Clinical Diagnostics Inc

Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY

MEDLINE INDUSTRIES, LP - Northfield

BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887

Becton Dickinson & Co.

CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit

Caire, Inc.

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software

Olympus Corporation of the Americas

This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contain

Stryker Corporation

Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff

Mirion Technologies (Capintec), Inc.

IntelePACS - InteleConnect / TechPortal

INTELERAD MEDICAL SYSTEMS INCORPORATED