Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
The Anspach Effort, Inc.
Electronic Foot Control with Direction Switch Product Usage: Electric system
Medical Devices·209 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
10.5cm QD Angle Attachment Product Usage: Pneumatic system
Medical Devices·203 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
IMRI MOTOR Product Usage: Pneumatic system
Medical Devices·3 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
Foot Control, SC2100 Product Usage: Electric system
Medical Devices·320 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
22CM MICRO REVISION ATTACH, BLACK MAX
Medical Devices·25 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
Autolube-III with NK Product Usage: Pneumatic system
Medical Devices·1 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
Medical Devices·821 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system
Medical Devices·17 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
Adult Craniotome Product Usage: Pneumatic system
Medical Devices·2,878 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
20.2cm Heavy Duty Long Heavy Short Attachment
Medical Devices·206 affected·Oct 6, 2016
CriticalFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or olde...
Medical Devices·11,860 affected·Oct 5, 2016
CriticalFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No...
Medical Devices·3,337 affected·Oct 5, 2016
CriticalFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 ...
Medical Devices·10,516 affected·Oct 5, 2016
CriticalFDA
Inpeco S.a.
FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, s...
Medical Devices·188 affected·Oct 4, 2016
High RiskFDA
Medtronic
Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to...
Medical Devices·230 affected·Oct 4, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
Medical Devices·4,976 affected·Oct 4, 2016
High RiskFDA
Medtronic
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedure...
Medical Devices·1,293,169 affected·Oct 4, 2016
High RiskFDA
Synthes (usa) Products Llc
Extraction Hook - Sterile for TI Cannulated Nails
Medical Devices·114 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Medical Devices·319 affected·Oct 3, 2016
High RiskFDA
Medimaps Group
TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analy...
Medical Devices·15 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
3.0 mm Reaming Rod/950 mm, Sterile
Medical Devices·887 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
Medical Devices·139 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
Medical Devices·2,157 affected·Oct 3, 2016
High RiskFDA
Nova Ortho-med Inc
4205 Journey Rolling Walker Product Usage: used to assist people in walking
Medical Devices·1,380 affected·Oct 1, 2016
High RiskFDA
Gf Health Products, Inc
Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Des...
Medical Devices·3,547 affected·Sep 30, 2016
High RiskFDA
Bayer Healthcare
PET Infusion Pump
Medical Devices·165,127 affected·Sep 30, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Aptio Automation Modules
Medical Devices·448 affected·Sep 29, 2016
High RiskFDA
Elekta, Inc.
Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy....
Medical Devices·365 affected·Sep 29, 2016
High RiskFDA
Baxter Healthcare Corp.
V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE...
Medical Devices·439 affected·Sep 28, 2016
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and ...
Medical Devices·305 affected·Sep 27, 2016
RecallFDA
Acumedia Manufacturers, Inc.
Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease produ...
Medical Devices·28 affected·Sep 25, 2016
High RiskFDA
Merit Medical Systems, Inc.
Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
Medical Devices·130 affected·Sep 23, 2016
High RiskFDA
Cardinal Health 200, Llc
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
Medical Devices·72,076 affected·Sep 23, 2016
High RiskFDA
Merit Medical Systems, Inc.
Manifold Kit. Catalog Number K09-11867AP
Medical Devices·40 affected·Sep 23, 2016
High RiskFDA
Merit Medical Systems, Inc.
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Medical Devices·53 affected·Sep 23, 2016
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 ...
Medical Devices·14 affected·Sep 21, 2016
High RiskFDA
Custom Medical Specialties, Inc.
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties,...
Medical Devices·80 affected·Sep 20, 2016
High RiskFDA
New Star Lasers, Inc.
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tis...
Medical Devices·5 affected·Sep 19, 2016
High RiskFDA
New Star Lasers, Inc.
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablatio...
Medical Devices·44 affected·Sep 19, 2016
High RiskFDA
Philips Electronics North America Corporation
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchang...
Medical Devices·1,824 affected·Sep 19, 2016
High RiskFDA
Natus Medical Incorporated
Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, op...
Medical Devices·713 affected·Sep 16, 2016
High RiskFDA
Becton Dickinson & Company
BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professional...
Medical Devices·547,600 affected·Sep 16, 2016
High RiskFDA
Ion Beam Applications S.a.
Proteus ONE and Proteus Plus
Medical Devices·0 affected·Sep 16, 2016
High RiskFDA
Becton Dickinson & Company
BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
Medical Devices·22,400 affected·Sep 16, 2016
High RiskFDA
Becton Dickinson & Company
BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for ...
Medical Devices·648,000 affected·Sep 16, 2016
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information manageme...
Medical Devices·251 affected·Sep 15, 2016
CriticalFDA
Sentec Ag
SDMS (SenTec Digital Monitoring System)
Medical Devices·75 affected·Sep 15, 2016
CriticalFDA
Battle Creek Equipment Co.
Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, P...
Medical Devices·99,060 affected·Sep 15, 2016