RecallHawk

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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