RecallHawk

Medical Device Recalls

FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.

13,708 total recalls

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.

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

Philips North America 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.

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875

Medline Industries, LP

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

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047;

GE Healthcare

Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL

Stryker Corporation

EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovasc

Boston Scientific Corporation

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Softwa

Siemens Healthcare Diagnostics Inc

HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Te

Stradis Healthcare

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