Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,708 total recalls
Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
Cardinal Health 200, LLC
Model Number L101, ESSENTIO DR SL Pacemaker
Boston Scientific Corporation
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000910;
Beaver Visitec International, Inc.
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Number
ICU Medical Inc
ProxiDiagnost N90. radiography and fluoroscopy system
Philips Medical Systems DMC GmbH
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Baxter Healthcare Corporation
Brand Name: MEDLINE Product Name: SYR 10ML L/L RED HEPARIN Model/Catalog Number: 91851 Product Description: NON-Steri
Jiangsu Shenli Medical Production Co., Ltd.
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (trache
Sklar Instruments
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powere
SURGIFY MEDICAL OY
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Centinel Spine, Inc.
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurio
Philips North America Llc
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w
ROi CPS LLC
SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in
Integra LifeSciences Corp.
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
Encore Medical, LP
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
B. Braun Medical, Inc.
DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
AVID Medical, Inc.
Braun Thermoscan¿ PRO 6000 Ear Thermometer
Baxter Healthcare Corporation
Flamingo Funnel Small, Model Number SQ20012-01
SurgiSmoke Solutions
Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic,
Philips North America Llc
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17
American Contract Systems Inc.
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated
Zimmer, Inc.
Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
Stradis Medical, LLC dba Stradis Healthcare
INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
Abbott Vascular
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
TELEFLEX LLC
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
Stryker Corporation
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Pr
Fujirebio Diagnostics, Inc.
ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomogra
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall a
Abbott Molecular, Inc.
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