Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,708 total recalls
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Defibtech, LLC
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for pati
Breas Medical, Inc.
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e
Siemens Healthcare Diagnostics Inc
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
Medline Industries, LP
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstatio
Draeger Medical, Inc.
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Siemens Medical Solutions USA, Inc
Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M
Medline Industries, LP
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated ca
Merge Healthcare, Inc.
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
MEDLINE INDUSTRIES, LP - Northfield
HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787
Stradis Medical, LLC dba Stradis Healthcare
Lactose Intolerance Test
GET TESTED INTERNATIONAL AB
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter
Boston Scientific Corporation
Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST
Medline Industries, LP
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front
Olympus Corporation of the Americas
Foundation Kit
Stradis Medical, LLC dba Stradis Healthcare
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
MEDLINE INDUSTRIES, LP - Northfield
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
CardioQuip, LLC
Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 100018
Abbott Vascular
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-0
Datascope Corp.
Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54
Invacare Corporation
stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
Tornier S.A.S.
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011
Instrumentation Laboratory
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascul
Cook Incorporated
GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position
Galt Medical Corporation
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Co
Abiomed, Inc.
Nasal Sinus Pack, MTSN26B; Medical convenience kit
American Contract Systems, Inc.
KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
Cardinal Health 200, LLC
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G
American Contract Systems Inc
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