Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,586 total recalls
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Numbe
Medline Industries, LP
WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende
Boston Scientific Corporation
ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultra
National Distribution & Contracting Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surgical devic
Carefusion 2200 Inc
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
DeRoyal Industries Inc
Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05090-I
Applied Medical Technology Inc
AirFit N10 Nasal Masks and User Guide
ResMed Ltd.
GI Microbiome Profile Small
GET TESTED INTERNATIONAL AB
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Straumann USA LLC
HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930
Stradis Medical, LLC dba Stradis Healthcare
Cath Cardiac Pack, REF IHCC03V
American Contract Systems, Inc.
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (inclu
GE Medical Systems, LLC
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Abbott Molecular, Inc.
PrisMax System, Product Code 955724
Baxter Healthcare Corporation
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
K2M, Inc.
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Siemens Medical Solutions USA, Inc
iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needl
Alcor Scientific, Inc.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe
Medline Industries, LP
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation monitoring dosimete
Landauer
Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product Description: NON-Sterile syri
Jiangsu Shenli Medical Production Co., Ltd.
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery
W L Gore & Associates, Inc.
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Maquet Cardiovascular, LLC
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Philips North America Llc
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing softw
Blue Belt Technologies, Inc
Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingiv
Dental EZ Group Star Dental Division
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000749;
Beaver Visitec International, Inc.
Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic dev
Philips North America Llc
Functional MR V1.0
OLEA MEDICAL
GEN LAPAROSCOPY PACK. Medical convenience kit.
AVID Medical, Inc.
DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07
Universal Meditech Inc.
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