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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