Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 92 of 548
FDA Devices Moderate Jan 24, 2024
Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
Getinge Usa Sales Inc
FDA Devices Moderate Jan 24, 2024
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
Smiths Medical Asd Inc
FDA Devices Moderate Jan 24, 2024
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Olympus Corporation of the Americas
FDA Devices Moderate Jan 24, 2024
Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD568221561C, X10…
Getinge Usa Sales Inc
FDA Devices Critical Jan 24, 2024
regard Operative LAP, Item Number 800943001; surgical convenience kit
ROi CPS LLC
FDA Devices Moderate Jan 17, 2024
Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
Shirakawa Olympus Co., Ltd.
FDA Devices Moderate Jan 17, 2024
Sensis Vibe Hemo
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jan 17, 2024
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation eq…
Olympus Corporation of the Americas
FDA Devices Moderate Jan 17, 2024
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power ch…
mo-Vis BVBA
FDA Devices Moderate Jan 17, 2024
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the …
Abiomed, Inc.
FDA Devices Moderate Jan 17, 2024
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code …
Baxter Healthcare Corporation
FDA Devices Moderate Jan 17, 2024
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. …
Abiomed, Inc.
FDA Devices Moderate Jan 17, 2024
Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
Baxter Healthcare Corporation
FDA Devices Moderate Jan 17, 2024
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FIL…
BioFire Diagnostics, LLC
FDA Devices Moderate Jan 17, 2024
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
Townsend Design
FDA Devices Moderate Jan 17, 2024
QMS Tacrolimus Calibrators, Product code 10015573
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Jan 17, 2024
VADER pedicle system, torque wrench, Catalog Number 42-702
Icotec Ag
FDA Devices Moderate Jan 17, 2024
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
Shirakawa Olympus Co., Ltd.
FDA Devices Moderate Jan 17, 2024
BrightView X, Gamma Camera, Product Code 882478
Philips North America
FDA Devices Moderate Jan 17, 2024
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
Philips North America
FDA Devices Moderate Jan 17, 2024
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Blue Belt Technologies, Inc
FDA Devices Moderate Jan 17, 2024
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuo…
Abbott Laboratories
FDA Devices Moderate Jan 17, 2024
Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TS; c) VG0106: 1 X 6 CM US,…
Baxter Healthcare Corporation
FDA Devices Moderate Jan 17, 2024
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Medtronic Navigation, Inc.
FDA Devices Moderate Jan 17, 2024
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 I…
Abiomed, Inc.
FDA Devices Moderate Jan 17, 2024
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the bo…
Abiomed, Inc.
FDA Devices Moderate Jan 17, 2024
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) …
Baxter Healthcare Corporation
FDA Devices Moderate Jan 17, 2024
Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
Shirakawa Olympus Co., Ltd.
FDA Devices Moderate Jan 17, 2024
Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883
Baxter Healthcare Corporation
FDA Devices Moderate Jan 17, 2024
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Produ…
Baxter Healthcare Corporation
FDA Devices Moderate Jan 17, 2024
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous…
Abbott Laboratories
FDA Devices Moderate Jan 17, 2024
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
SoClean, Inc
FDA Devices Moderate Jan 17, 2024
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Cordis US Corp
FDA Devices Moderate Jan 17, 2024
PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X…
Baxter Healthcare Corporation
FDA Devices Moderate Jan 17, 2024
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Medtronic Navigation, Inc.
FDA Devices Moderate Jan 17, 2024
Model No. BF-XP190, EVIS EXERA III Bronchovideoscope
Shirakawa Olympus Co., Ltd.
FDA Devices Moderate Jan 17, 2024
Detector H. Pylori, Catalog Number IHP-30
Immunostics, Inc.
FDA Devices Moderate Jan 17, 2024
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Becton, Dickinson and Company, BD Biosciences
FDA Devices Moderate Jan 17, 2024
BrightView, Gamma Camera System, Product Code 882480.
Philips North America
FDA Devices Moderate Jan 17, 2024
Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
Shirakawa Olympus Co., Ltd.
FDA Devices Moderate Jan 17, 2024
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. …
Abiomed, Inc.
FDA Devices Moderate Jan 17, 2024
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed…
Abbott Laboratories
FDA Devices Moderate Jan 17, 2024
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jan 17, 2024
Model No. CYF-5R, Cystonephrofiberscope
Shirakawa Olympus Co., Ltd.
FDA Devices Moderate Jan 17, 2024
BrightView XCT, Gamma Camera, Product Code 882482
Philips North America
FDA Devices Moderate Jan 17, 2024
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Philips Healthcare (Suzhou) Co., Ltd.
FDA Devices Moderate Jan 17, 2024
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the bo…
Abiomed, Inc.
FDA Devices Moderate Jan 17, 2024
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Ambu Inc.
FDA Devices Moderate Jan 17, 2024
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the f…
Boston Scientific Corporation
FDA Devices Moderate Jan 17, 2024
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 822…
Medtronic Xomed, Inc.