Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,583 total recalls
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Acclarent, Inc.
Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B
MEDLINE INDUSTRIES, LP - Northfield
BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerob
Becton Dickinson & Co.
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Uromedica Inc.
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog
Becton Dickinson & Co.
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Siemens Medical Solutions USA, Inc
Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrum
Nextremity Solutions
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain
Abbott Molecular, Inc.
DeRoyal CRANI PACK, REF 89-10202.05
DeRoyal Industries Inc
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03
Linkbio Corp.
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
American Contract Systems Inc
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with
Medtronic Neuromodulation
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
Hollister Incorporated
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Ster
MEDLINE INDUSTRIES, LP - Northfield
Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
Olympus Corporation of the Americas
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2
Medtronic Sofamor Danek USA Inc
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
SEDECAL SA
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter,
Cook Inc.
Digital Angiography System Bransist safire Generator Model D150GC-40
Shimadzu Medical Systems
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-1
Encore Medical, LP
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3.
Vortex Surgical Inc.
Vivoo Protein Test
Changchun Wancheng Bio-Electron Co., Ltd.
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad
Elucent Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus
B Braun Medical Inc
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Per
TELEFLEX MEDICAL INC
Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
Mckesson Medical-Surgical Inc. Corporate Office
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, sta
Baxter Healthcare Corporation
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Beckman Coulter Inc.
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Abiomed, Inc.
ALLURA Xper FD10F; System Code: 722002;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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