Medical Device Recalls

Surpria 64: Software Version V3.11, V3.22

FUJIFILM Healthcare Americas Corporation

American Contract Systems Spine Pack convenience kit

American Contract Systems, Inc.

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F

Vyaire Medical

bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound sy

B-K Medical A/S

ARTIS Pheno VE30A and VE40A, Model 10849000

Siemens Medical Solutions USA, Inc

GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System

GE Medical Systems SCS

Strep Selective II Agar, Product Number R01859

Remel, Inc

cobas e801 Immunoassay Analyzer

Roche Diagnostics Operations, Inc.

Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can p

Philips North America Llc

DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images

Philips North America Llc

Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated

Cardinal Health 200, LLC

5008X CAREsystem +CLiC +CDX;

Fresenius Medical Care Holdings, Inc.

prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5

Centinel Spine, Inc.

Major Vascular CDS Convenience Kit

Medline Industries Inc

DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01

FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD

VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged

Greiner Bio-One North America, Inc.

Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm

Securitas Healthcare LLC

Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270

MEDLINE INDUSTRIES, LP - Northfield

VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984;

Biomerieux Inc

System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee b

Siemens Medical Solutions USA, Inc

UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478

Beckman Coulter Inc.

MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611

Covidien LP

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780055

TELEFLEX LLC

BD Trucount Controls, 30 Test - REF: 340335

Becton, Dickinson and Company, BD Bio Sciences

Olympus OER-Elite

Aizu Olympus Co., Ltd.

ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS i

Siemens Medical Solutions USA, Inc

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

Refer to RES or lead review memo for complete list of affected reference/catalog numbers

MEDLINE INDUSTRIES, LP - Northfield

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12

Linkbio Corp.

Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ

MEDLINE INDUSTRIES, LP - Northfield